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GMRS

Model 6495-5-211 · Howmedica Osteonics Corp. · DI 07613327033656

KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3510

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

UDILibrary device dossier · generated 2026-09-14 · 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 (1)

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.

Injury: 1

12232019-01: 0 reports for this device; peer average 2.68/device2019-02: 0 reports for this device; peer average 2.55/device2019-03: 0 reports for this device; peer average 2.7/device2019-04: 0 reports for this device; peer average 2.56/device2019-05: 1 reports for this device; peer average 2.04/device2019-06: 0 reports for this device; peer average 1.83/device2019-07: 0 reports for this device; peer average 1.82/device2019-08: 0 reports for this device; peer average 2.21/device2019-09: 0 reports for this device; peer average 2.17/device2019-10: 0 reports for this device; peer average 2.4/device2019-11: 0 reports for this device; peer average 2.17/device2019-12: 0 reports for this device; peer average 2.57/device2020-01: 0 reports for this device; peer average 2.95/device2020-02: 0 reports for this device; peer average 2.51/device2020-03: 0 reports for this device; peer average 3.13/device2020-04: 0 reports for this device; peer average 2.48/device2020-05: 0 reports for this device; peer average 2.56/device2020-06: 0 reports for this device; peer average 2.1/device2020-07: 0 reports for this device; peer average 2.56/device2020-08: 0 reports for this device; peer average 2.15/device2020-09: 0 reports for this device; peer average 2.72/device2020-10: 0 reports for this device; peer average 2.82/device2020-11: 0 reports for this device; peer average 2.39/device2020-12: 0 reports for this device; peer average 2.39/device2021-01: 0 reports for this device; peer average 2.39/device2021-02: 0 reports for this device; peer average 2.19/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 2.16/device2021-05: 0 reports for this device; peer average 2.26/device2021-06: 0 reports for this device; peer average 2.46/device2021-07: 0 reports for this device; peer average 2.69/device2021-08: 0 reports for this device; peer average 2.55/device2021-09: 0 reports for this device; peer average 2.78/device2021-10: 0 reports for this device; peer average 2.42/device2021-11: 0 reports for this device; peer average 2.44/device2021-12: 0 reports for this device; peer average 2.6/device2022-01: 0 reports for this device; peer average 2.39/device2022-02: 0 reports for this device; peer average 2.7/device2022-03: 0 reports for this device; peer average 2.31/device2022-04: 0 reports for this device; peer average 2.4/device2022-05: 0 reports for this device; peer average 2.48/device2022-06: 0 reports for this device; peer average 2.35/device2022-07: 0 reports for this device; peer average 2.31/device2022-08: 0 reports for this device; peer average 2.37/device2022-09: 0 reports for this device; peer average 2.37/device2022-10: 0 reports for this device; peer average 2.37/device2022-11: 0 reports for this device; peer average 2.58/device2022-12: 0 reports for this device; peer average 2.56/device2023-01: 0 reports for this device; peer average 2.52/device2023-02: 0 reports for this device; peer average 2.3/device2023-03: 0 reports for this device; peer average 2.45/device2023-04: 0 reports for this device; peer average 2.39/device2023-05: 0 reports for this device; peer average 2.41/device2023-06: 0 reports for this device; peer average 2.51/device2023-07: 0 reports for this device; peer average 2.31/device2023-08: 0 reports for this device; peer average 2.13/device2023-09: 0 reports for this device; peer average 2.14/device2023-10: 0 reports for this device; peer average 1.74/device2023-11: 0 reports for this device; peer average 1.76/device2023-12: 0 reports for this device; peer average 1.85/device2024-01: 0 reports for this device; peer average 1.87/device2024-02: 0 reports for this device; peer average 2.16/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1.85/device2024-05: 0 reports for this device; peer average 2.26/device2024-06: 0 reports for this device; peer average 1.95/device2024-07: 0 reports for this device; peer average 1.81/device2024-08: 0 reports for this device; peer average 1.97/device2024-09: 0 reports for this device; peer average 2.14/device2024-10: 0 reports for this device; peer average 1.91/device2024-11: 0 reports for this device; peer average 1.95/device2024-12: 0 reports for this device; peer average 1.7/device2025-01: 0 reports for this device; peer average 2.14/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 1.81/device2025-04: 0 reports for this device; peer average 1.96/device2025-05: 0 reports for this device; peer average 1.94/device2025-06: 0 reports for this device; peer average 1.96/device2025-07: 0 reports for this device; peer average 1.91/device2025-08: 0 reports for this device; peer average 1.99/device2025-09: 0 reports for this device; peer average 1.85/device2025-10: 0 reports for this device; peer average 1.86/device2025-11: 0 reports for this device; peer average 2.03/device2025-12: 0 reports for this device; peer average 2.05/device2026-01: 0 reports for this device; peer average 2.2/device2026-02: 0 reports for this device; peer average 1.9/device2026-03: 0 reports for this device; peer average 2.15/device2026-04: 0 reports for this device; peer average 2.06/device2026-05: 0 reports for this device; peer average 2.05/device2026-06: 0 reports for this device; peer average 1.84/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.68
2019-0202.55
2019-0302.7
2019-0402.56
2019-0512.04
2019-0601.83
2019-0701.82
2019-0802.21
2019-0902.17
2019-1002.4
2019-1102.17
2019-1202.57
2020-0102.95
2020-0202.51
2020-0303.13
2020-0402.48
2020-0502.56
2020-0602.1
2020-0702.56
2020-0802.15
2020-0902.72
2020-1002.82
2020-1102.39
2020-1202.39
2021-0102.39
2021-0202.19
2021-0302.2
2021-0402.16
2021-0502.26
2021-0602.46
2021-0702.69
2021-0802.55
2021-0902.78
2021-1002.42
2021-1102.44
2021-1202.6
2022-0102.39
2022-0202.7
2022-0302.31
2022-0402.4
2022-0502.48
2022-0602.35
2022-0702.31
2022-0802.37
2022-0902.37
2022-1002.37
2022-1102.58
2022-1202.56
2023-0102.52
2023-0202.3
2023-0302.45
2023-0402.39
2023-0502.41
2023-0602.51
2023-0702.31
2023-0802.13
2023-0902.14
2023-1001.74
2023-1101.76
2023-1201.85
2024-0101.87
2024-0202.16
2024-0302
2024-0401.85
2024-0502.26
2024-0601.95
2024-0701.81
2024-0801.97
2024-0902.14
2024-1001.91
2024-1101.95
2024-1201.7
2025-0102.14
2025-0201.67
2025-0301.81
2025-0401.96
2025-0501.94
2025-0601.96
2025-0701.91
2025-0801.99
2025-0901.85
2025-1001.86
2025-1102.03
2025-1202.05
2026-0102.2
2026-0201.9
2026-0302.15
2026-0402.06
2026-0502.05
2026-0601.84
This device (reports/month)Average device in KRO, LZO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K022403 — cited as predicate by K222056, K241716

K023087 — cited as predicate by K092138, K121029, K121055, K121056, K122015, K151008, K190100, K222056, K223528, K233261, K241059, K241716, K251665

K031217 — cited as predicate by K222056, K241716

K222056 — cites (transitively): K002552 (d1), K022403 (d1), K023087 (d1), K031217 (d1), K032581 (d1), K040749 (d1), K952970 (d1) — cited as predicate by K230416, K233261, K241716, K251665

K241716 — cites (transitively): K002552 (d1), K022403 (d1), K023087 (d1), K031217 (d1), K032581 (d1), K040749 (d1), K222056 (d1), K233261 (d1), K952970 (d1)

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

Manufacturer compliance record — Howmedica Osteonics Corp.

  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • NAI 2021-06-22 Howmedica Osteonics Corp. · 0 citations
  • VAI 2015-03-09 Howmedica Osteonics Corp. · 3 citations
  • VAI 2013-04-16 Howmedica Osteonics Corp. · 3 citations
  • NAI 2010-01-15 Howmedica Osteonics Corp. · 0 citations