Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

2.0 mm Pin Repositioner, Even

Model 501829-0200 · Si-Bone Inc. · DI 00810055523702

LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540

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

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

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.

12452019-01: 0 reports for this device; peer average 2.51/device2019-02: 0 reports for this device; peer average 2.74/device2019-03: 0 reports for this device; peer average 2.63/device2019-04: 0 reports for this device; peer average 2.35/device2019-05: 0 reports for this device; peer average 2.56/device2019-06: 0 reports for this device; peer average 2.48/device2019-07: 0 reports for this device; peer average 2.65/device2019-08: 0 reports for this device; peer average 2.52/device2019-09: 0 reports for this device; peer average 2.75/device2019-10: 0 reports for this device; peer average 2.65/device2019-11: 0 reports for this device; peer average 3.16/device2019-12: 0 reports for this device; peer average 2.69/device2020-01: 0 reports for this device; peer average 2.72/device2020-02: 0 reports for this device; peer average 3.12/device2020-03: 0 reports for this device; peer average 2.86/device2020-04: 0 reports for this device; peer average 3.86/device2020-05: 0 reports for this device; peer average 2.16/device2020-06: 0 reports for this device; peer average 2.91/device2020-07: 0 reports for this device; peer average 3.71/device2020-08: 0 reports for this device; peer average 3.16/device2020-09: 0 reports for this device; peer average 3.6/device2020-10: 0 reports for this device; peer average 4.49/device2020-11: 0 reports for this device; peer average 4.17/device2020-12: 0 reports for this device; peer average 3.77/device2021-01: 0 reports for this device; peer average 4.02/device2021-02: 0 reports for this device; peer average 3.78/device2021-03: 0 reports for this device; peer average 3.38/device2021-04: 0 reports for this device; peer average 3.59/device2021-05: 0 reports for this device; peer average 3.41/device2021-06: 0 reports for this device; peer average 3.23/device2021-07: 0 reports for this device; peer average 2.82/device2021-08: 0 reports for this device; peer average 3.15/device2021-09: 0 reports for this device; peer average 2.82/device2021-10: 0 reports for this device; peer average 2.45/device2021-11: 0 reports for this device; peer average 3.34/device2021-12: 0 reports for this device; peer average 2.68/device2022-01: 0 reports for this device; peer average 2.59/device2022-02: 0 reports for this device; peer average 3.14/device2022-03: 0 reports for this device; peer average 3.21/device2022-04: 0 reports for this device; peer average 3.09/device2022-05: 0 reports for this device; peer average 3.78/device2022-06: 0 reports for this device; peer average 3.14/device2022-07: 0 reports for this device; peer average 2.66/device2022-08: 0 reports for this device; peer average 2.67/device2022-09: 0 reports for this device; peer average 2.7/device2022-10: 0 reports for this device; peer average 3.24/device2022-11: 0 reports for this device; peer average 3.56/device2022-12: 0 reports for this device; peer average 3.87/device2023-01: 0 reports for this device; peer average 4.27/device2023-02: 0 reports for this device; peer average 3.18/device2023-03: 0 reports for this device; peer average 3.67/device2023-04: 0 reports for this device; peer average 3.12/device2023-05: 0 reports for this device; peer average 3.15/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 2.81/device2023-08: 0 reports for this device; peer average 2.81/device2023-09: 0 reports for this device; peer average 2.7/device2023-10: 0 reports for this device; peer average 2.63/device2023-11: 0 reports for this device; peer average 4.52/device2023-12: 0 reports for this device; peer average 3.33/device2024-01: 0 reports for this device; peer average 3.03/device2024-02: 0 reports for this device; peer average 3.35/device2024-03: 0 reports for this device; peer average 3.08/device2024-04: 0 reports for this device; peer average 3.67/device2024-05: 0 reports for this device; peer average 3.78/device2024-06: 0 reports for this device; peer average 3.81/device2024-07: 0 reports for this device; peer average 3.1/device2024-08: 0 reports for this device; peer average 3.3/device2024-09: 0 reports for this device; peer average 3.46/device2024-10: 0 reports for this device; peer average 3.98/device2024-11: 0 reports for this device; peer average 3.42/device2024-12: 0 reports for this device; peer average 3.08/device2025-01: 0 reports for this device; peer average 4.9/device2025-02: 0 reports for this device; peer average 4.24/device2025-03: 0 reports for this device; peer average 4.51/device2025-04: 0 reports for this device; peer average 3.19/device2025-05: 0 reports for this device; peer average 3.34/device2025-06: 0 reports for this device; peer average 3.26/device2025-07: 0 reports for this device; peer average 3.04/device2025-08: 0 reports for this device; peer average 3.32/device2025-09: 0 reports for this device; peer average 2.74/device2025-10: 0 reports for this device; peer average 2.85/device2025-11: 0 reports for this device; peer average 3.18/device2025-12: 0 reports for this device; peer average 4.04/device2026-01: 0 reports for this device; peer average 3.85/device2026-02: 0 reports for this device; peer average 3.73/device2026-03: 0 reports for this device; peer average 3.49/device2026-04: 0 reports for this device; peer average 3.36/device2026-05: 0 reports for this device; peer average 3.3/device2026-06: 0 reports for this device; peer average 3.57/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.51
2019-0202.74
2019-0302.63
2019-0402.35
2019-0502.56
2019-0602.48
2019-0702.65
2019-0802.52
2019-0902.75
2019-1002.65
2019-1103.16
2019-1202.69
2020-0102.72
2020-0203.12
2020-0302.86
2020-0403.86
2020-0502.16
2020-0602.91
2020-0703.71
2020-0803.16
2020-0903.6
2020-1004.49
2020-1104.17
2020-1203.77
2021-0104.02
2021-0203.78
2021-0303.38
2021-0403.59
2021-0503.41
2021-0603.23
2021-0702.82
2021-0803.15
2021-0902.82
2021-1002.45
2021-1103.34
2021-1202.68
2022-0102.59
2022-0203.14
2022-0303.21
2022-0403.09
2022-0503.78
2022-0603.14
2022-0702.66
2022-0802.67
2022-0902.7
2022-1003.24
2022-1103.56
2022-1203.87
2023-0104.27
2023-0203.18
2023-0303.67
2023-0403.12
2023-0503.15
2023-0603
2023-0702.81
2023-0802.81
2023-0902.7
2023-1002.63
2023-1104.52
2023-1203.33
2024-0103.03
2024-0203.35
2024-0303.08
2024-0403.67
2024-0503.78
2024-0603.81
2024-0703.1
2024-0803.3
2024-0903.46
2024-1003.98
2024-1103.42
2024-1203.08
2025-0104.9
2025-0204.24
2025-0304.51
2025-0403.19
2025-0503.34
2025-0603.26
2025-0703.04
2025-0803.32
2025-0902.74
2025-1002.85
2025-1103.18
2025-1204.04
2026-0103.85
2026-0203.73
2026-0303.49
2026-0403.36
2026-0503.3
2026-0603.57
This device (reports/month)Average device in LXH, OLO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K241504 — cites (transitively): K161616 (d1), K203247 (d1), K012945 (d2), K021556 (d2), K021932 (d2), K050636 (d2), K080943 (d2), K090949 (d2), K112583 (d2), K962011 (d2), K963172 (d2), K963192 (d2), K162733 (d2), K171595 (d2), K191748 (d2), K193083 (d2), K193524 (d2), K000682 (d3), K000684 (d3), K023879 (d3), K100776 (d3), K150017 (d3), K160652 (d3), K000080 (d3), K024060 (d3), K082792 (d3), K091967 (d3), K112028 (d3), K130092 (d3), K080398 (d3), K092375 (d3), K123702 (d3), K141549 (d3), K161210 (d3), K080298 (d3), K110838 (d3), K190230 (d3), K014072 (d4), K050966 (d4), K072857 (d4), K073337 (d4), K082468 (d4), K982447 (d4), K061808 (d4), K063049 (d4), K090063 (d4), K090675 (d4), K102907 (d4), K102903 (d4), K122074 (d4), K123850 (d4), K131405 (d4), K141049 (d4), K150714 (d4), K150875 (d4), K151718 (d4), K152681 (d4), K110472 (d4), K111520 (d4), K124004 (d4), K140454 (d4), K150231 (d4), K182983 (d4), K051296 (d5), K914004 (d5), K061113 (d5), K061639 (d5), K063305 (d5), K081475 (d5), K050438 (d5), K131425 (d5), K121020 (d5), K102701 (d6), K111571 (d6), K073291 (d6), K083026 (d6), K103731 (d6), K112405 (d6), K090648 (d7), K011182 (d7), K070387 (d7), K073562 (d7), K080313 (d7), K102249 (d7), K062174 (d8) — cited as predicate by K253488

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

Manufacturer compliance record — Si-Bone Inc.

  • NAI 2025-06-12 Si-Bone, Inc. · 0 citations
  • NAI 2025-06-12 Si-Bone, Inc. · 0 citations
  • NAI 2022-03-31 SI-BONE, Inc. · 0 citations
  • NAI 2022-03-31 SI-BONE, Inc. · 0 citations
  • VAI 2014-05-20 SI-BONE, Inc. · 3 citations
  • VAI 2014-05-20 SI-BONE, Inc. · 3 citations