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ExactechGPS

Model 531-07-07 · Exactech, Inc. · DI 10885862635402

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2023-06-05Z-2050-2023Class IIOpen, ClassifiedThe ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.k number procode

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

25792019-01: 0 reports for this device; peer average 2.67/device2019-02: 0 reports for this device; peer average 3.61/device2019-03: 0 reports for this device; peer average 3.19/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 3.1/device2019-06: 0 reports for this device; peer average 2.72/device2019-07: 0 reports for this device; peer average 3.23/device2019-08: 0 reports for this device; peer average 2.93/device2019-09: 0 reports for this device; peer average 2.89/device2019-10: 0 reports for this device; peer average 3.84/device2019-11: 0 reports for this device; peer average 5.54/device2019-12: 0 reports for this device; peer average 3.54/device2020-01: 0 reports for this device; peer average 3.39/device2020-02: 0 reports for this device; peer average 4.56/device2020-03: 0 reports for this device; peer average 4.41/device2020-04: 0 reports for this device; peer average 7.69/device2020-05: 0 reports for this device; peer average 2.37/device2020-06: 0 reports for this device; peer average 3.54/device2020-07: 0 reports for this device; peer average 3.94/device2020-08: 0 reports for this device; peer average 2.61/device2020-09: 0 reports for this device; peer average 3.93/device2020-10: 0 reports for this device; peer average 5.63/device2020-11: 0 reports for this device; peer average 5.77/device2020-12: 0 reports for this device; peer average 4.33/device2021-01: 0 reports for this device; peer average 4.68/device2021-02: 0 reports for this device; peer average 4.08/device2021-03: 0 reports for this device; peer average 3.82/device2021-04: 0 reports for this device; peer average 3.82/device2021-05: 0 reports for this device; peer average 4.15/device2021-06: 0 reports for this device; peer average 3.79/device2021-07: 0 reports for this device; peer average 3.25/device2021-08: 0 reports for this device; peer average 2.96/device2021-09: 0 reports for this device; peer average 2.92/device2021-10: 0 reports for this device; peer average 2.27/device2021-11: 0 reports for this device; peer average 4.24/device2021-12: 0 reports for this device; peer average 2.72/device2022-01: 0 reports for this device; peer average 2.54/device2022-02: 0 reports for this device; peer average 3.16/device2022-03: 0 reports for this device; peer average 3.32/device2022-04: 0 reports for this device; peer average 2.45/device2022-05: 0 reports for this device; peer average 3.91/device2022-06: 0 reports for this device; peer average 4.21/device2022-07: 0 reports for this device; peer average 3.33/device2022-08: 0 reports for this device; peer average 2.9/device2022-09: 0 reports for this device; peer average 2.32/device2022-10: 0 reports for this device; peer average 3.76/device2022-11: 0 reports for this device; peer average 3.44/device2022-12: 0 reports for this device; peer average 4.22/device2023-01: 0 reports for this device; peer average 3.18/device2023-02: 0 reports for this device; peer average 3.44/device2023-03: 0 reports for this device; peer average 3.77/device2023-04: 0 reports for this device; peer average 3.26/device2023-05: 0 reports for this device; peer average 3.02/device2023-06: 0 reports for this device; peer average 2.6/device2023-07: 0 reports for this device; peer average 2.69/device2023-08: 0 reports for this device; peer average 2.51/device2023-09: 0 reports for this device; peer average 4.04/device2023-10: 0 reports for this device; peer average 3.21/device2023-11: 0 reports for this device; peer average 9.13/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 3.71/device2024-02: 0 reports for this device; peer average 4.15/device2024-03: 0 reports for this device; peer average 4.4/device2024-04: 0 reports for this device; peer average 3.95/device2024-05: 0 reports for this device; peer average 4.89/device2024-06: 0 reports for this device; peer average 4.54/device2024-07: 0 reports for this device; peer average 3.92/device2024-08: 0 reports for this device; peer average 4.59/device2024-09: 0 reports for this device; peer average 4.53/device2024-10: 0 reports for this device; peer average 6.31/device2024-11: 0 reports for this device; peer average 4.74/device2024-12: 0 reports for this device; peer average 4.01/device2025-01: 0 reports for this device; peer average 8.37/device2025-02: 0 reports for this device; peer average 4.23/device2025-03: 0 reports for this device; peer average 3.59/device2025-04: 0 reports for this device; peer average 4.2/device2025-05: 0 reports for this device; peer average 4.57/device2025-06: 0 reports for this device; peer average 4.14/device2025-07: 0 reports for this device; peer average 4.32/device2025-08: 0 reports for this device; peer average 5.03/device2025-09: 0 reports for this device; peer average 3.85/device2025-10: 0 reports for this device; peer average 3.97/device2025-11: 0 reports for this device; peer average 4.12/device2025-12: 0 reports for this device; peer average 4.59/device2026-01: 0 reports for this device; peer average 4.53/device2026-02: 0 reports for this device; peer average 4.25/device2026-03: 0 reports for this device; peer average 4.08/device2026-04: 0 reports for this device; peer average 3.9/device2026-05: 0 reports for this device; peer average 4.99/device2026-06: 0 reports for this device; peer average 3.99/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.67
2019-0203.61
2019-0303.19
2019-0402.75
2019-0503.1
2019-0602.72
2019-0703.23
2019-0802.93
2019-0902.89
2019-1003.84
2019-1105.54
2019-1203.54
2020-0103.39
2020-0204.56
2020-0304.41
2020-0407.69
2020-0502.37
2020-0603.54
2020-0703.94
2020-0802.61
2020-0903.93
2020-1005.63
2020-1105.77
2020-1204.33
2021-0104.68
2021-0204.08
2021-0303.82
2021-0403.82
2021-0504.15
2021-0603.79
2021-0703.25
2021-0802.96
2021-0902.92
2021-1002.27
2021-1104.24
2021-1202.72
2022-0102.54
2022-0203.16
2022-0303.32
2022-0402.45
2022-0503.91
2022-0604.21
2022-0703.33
2022-0802.9
2022-0902.32
2022-1003.76
2022-1103.44
2022-1204.22
2023-0103.18
2023-0203.44
2023-0303.77
2023-0403.26
2023-0503.02
2023-0602.6
2023-0702.69
2023-0802.51
2023-0904.04
2023-1003.21
2023-1109.13
2023-1204
2024-0103.71
2024-0204.15
2024-0304.4
2024-0403.95
2024-0504.89
2024-0604.54
2024-0703.92
2024-0804.59
2024-0904.53
2024-1006.31
2024-1104.74
2024-1204.01
2025-0108.37
2025-0204.23
2025-0303.59
2025-0404.2
2025-0504.57
2025-0604.14
2025-0704.32
2025-0805.03
2025-0903.85
2025-1003.97
2025-1104.12
2025-1204.59
2026-0104.53
2026-0204.25
2026-0304.08
2026-0403.9
2026-0504.99
2026-0603.99
This device (reports/month)Average device in OLO (reports/device/month)

Regulatory clearances

  • K213546 SESE 2022-01-06 (k number procode)

Predicate lineage

K162567 — cites (transitively): K042021 (d1), K063408 (d1), K063569 (d1), K093275 (d1), K093430 (d1), K103419 (d1), K110708 (d1), K113309 (d1), K121220 (d1), K131575 (d1), K151568 (d1), K152764 (d1), K061454 (d2), K133367 (d2), K100742 (d2), K022579 (d3), K060282 (d3), K073449 (d3), K123122 (d3), K092122 (d4) — cited as predicate by K173372

K173372 — cites (transitively): K162567 (d1), K042021 (d2), K063408 (d2), K063569 (d2), K093275 (d2), K093430 (d2), K103419 (d2), K110708 (d2), K113309 (d2), K121220 (d2), K131575 (d2), K151568 (d2), K152764 (d2), K061454 (d3), K133367 (d3), K100742 (d3), K022579 (d4), K060282 (d4), K073449 (d4), K123122 (d4), K092122 (d5) — cited as predicate by K210153, K213546, K222510

K213546 — cites (transitively): K042021 (d1), K061454 (d1), K063569 (d1), K082702 (d1), K093275 (d1), K162726 (d1), K173372 (d1), K180632 (d1), K203315 (d1), K060692 (d2), K080642 (d2), K162567 (d2), K102951 (d2), K110708 (d2), K131575 (d2), K162800 (d2), K170968 (d2), K063408 (d3), K093430 (d3), K103419 (d3), K113309 (d3), K121220 (d3), K151568 (d3), K152764 (d3), K101342 (d3), K111902 (d3), K132636 (d3), K151293 (d3), K153602 (d3), K160001 (d3), K160555 (d3), K160975 (d3), K110360 (d3), K131283 (d3), K142117 (d3), K162795 (d3), K063470 (d4), K060209 (d4), K060988 (d4), K063081 (d4), K103007 (d4), K952928 (d4), K994392 (d4), K073468 (d4), K100886 (d4), K123954 (d4), K133585 (d4), K140749 (d4), K030941 (d4), K041066 (d4), K050316 (d4), K051075 (d4), K061439 (d4), K081059 (d4), K092873 (d4), K100142 (d4), K112069 (d4), K122698 (d4), K132285 (d4), K140082 (d4), K140478 (d4), K140904 (d4), K133367 (d4), K100742 (d4), K080402 (d4), K100858 (d4), K110598 (d4), K111629 (d4), K113254 (d4), K130642 (d4), K130895 (d4), K131559 (d4), K133349 (d4), K142139 (d4), K143256 (d4), K073714 (d4), K142923 (d4), K112898 (d4), K143374 (d4), K150583 (d4), K110306 (d4), K153008 (d4), K022579 (d5), K060282 (d5), K030259 (d5), K063578 (d5), K992525 (d5), K073331 (d5), K022051 (d5), K021891 (d5), K070369 (d5), K072154 (d5), K102975 (d5), K850766 (d5), K851213 (d5), K934765 (d5), K953490 (d5), K960094 (d5), K974093 (d5), K974095 (d5), K053569 (d5), K111863 (d5), K073449 (d5), K123122 (d5), K053274 (d5), K081016 (d5), K091751 (d5), K101263 (d5), K111212 (d5), K113523 (d5), K030710 (d5), K112389 (d5), K130126 (d5), K131129 (d5), K051023 (d5), K103374 (d5), K070479 (d6), K030047 (d6), K030055 (d6), K031454 (d6), K042989 (d6), K050124 (d6), K052996 (d6), K102795 (d6), K110555 (d6), K810120 (d6), K861114 (d6), K861433 (d6), K911685 (d6), K920639 (d6), K920640 (d6), K921181 (d6), K921277 (d6), K921301 (d6), K926107 (d6), K954417 (d6), K970501 (d6), K991990 (d6), K092122 (d6), K050897 (d6), K093533 (d7), K032396 (d7), K042037 (d7), K042051 (d7), K062995 (d7), K101336 (d7), K082358 (d8), K050327 (d8), K070364 (d8), K070399 (d8), K072020 (d8), K083116 (d8), K093644 (d8), K100048 (d8) — cited as predicate by K230904, K232521, K233199, K240062, K242373, K252841

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Exactech, Inc.

  • Warning Letter 2025-12-19 Exactech Sarasota, Inc.
  • Warning Letter 2024-01-19 Exactech, Inc.
  • Warning Letter 2024-01-19 Exactech, Inc.
  • OAI 2025-08-27 Exactech, Inc. · 9 citations
  • OAI 2025-08-27 Exactech, Inc. · 9 citations
  • OAI 2025-07-25 Exactech Sarasota, Inc. · 7 citations
  • VAI 2024-10-09 Exactech, Inc. · 0 citations
  • VAI 2024-10-09 Exactech, Inc. · 0 citations
  • OAI 2023-09-26 Exactech, Inc. · 2 citations
  • OAI 2023-09-26 Exactech, Inc. · 2 citations
  • VAI 2021-11-17 Exactech, Inc. · 4 citations
  • VAI 2021-11-17 Exactech, Inc. · 4 citations
  • VAI 2020-01-31 Exactech, Inc. · 7 citations
  • VAI 2020-01-31 Exactech, Inc. · 7 citations
  • VAI 2017-03-10 Exactech, Inc. · 7 citations
  • VAI 2017-03-10 Exactech, Inc. · 7 citations
  • NAI 2015-07-16 Exactech, Inc. · 0 citations
  • NAI 2015-07-16 Exactech, Inc. · 0 citations
  • NAI 2014-08-25 Exactech Sarasota, Inc. · 0 citations
  • NAI 2012-12-11 Exactech, Inc. · 0 citations
  • NAI 2012-12-11 Exactech, Inc. · 0 citations
  • VAI 2010-03-25 Exactech, Inc. · 0 citations
  • VAI 2010-03-25 Exactech, Inc. · 0 citations