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GMRS

Model 6495-5-015 · Howmedica Osteonics Corp. · DI 07613327033526

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

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 2026-09-15 · 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.

12232019-01: 0 reports for this device; peer average 2.95/device2019-02: 0 reports for this device; peer average 2.6/device2019-03: 0 reports for this device; peer average 2.76/device2019-04: 0 reports for this device; peer average 2.65/device2019-05: 0 reports for this device; peer average 2.1/device2019-06: 0 reports for this device; peer average 1.86/device2019-07: 0 reports for this device; peer average 1.9/device2019-08: 0 reports for this device; peer average 2.15/device2019-09: 0 reports for this device; peer average 2.27/device2019-10: 0 reports for this device; peer average 2.43/device2019-11: 0 reports for this device; peer average 2.08/device2019-12: 0 reports for this device; peer average 2.47/device2020-01: 0 reports for this device; peer average 2.82/device2020-02: 0 reports for this device; peer average 2.53/device2020-03: 0 reports for this device; peer average 3.22/device2020-04: 0 reports for this device; peer average 2.35/device2020-05: 0 reports for this device; peer average 2.47/device2020-06: 0 reports for this device; peer average 2.01/device2020-07: 0 reports for this device; peer average 2.53/device2020-08: 0 reports for this device; peer average 2.05/device2020-09: 0 reports for this device; peer average 2.54/device2020-10: 0 reports for this device; peer average 2.66/device2020-11: 0 reports for this device; peer average 2.28/device2020-12: 0 reports for this device; peer average 2.3/device2021-01: 0 reports for this device; peer average 2.32/device2021-02: 0 reports for this device; peer average 2.09/device2021-03: 0 reports for this device; peer average 2.11/device2021-04: 0 reports for this device; peer average 2.05/device2021-05: 0 reports for this device; peer average 2.13/device2021-06: 0 reports for this device; peer average 2.42/device2021-07: 0 reports for this device; peer average 2.49/device2021-08: 0 reports for this device; peer average 2.28/device2021-09: 0 reports for this device; peer average 2.51/device2021-10: 0 reports for this device; peer average 2.25/device2021-11: 0 reports for this device; peer average 2.3/device2021-12: 0 reports for this device; peer average 2.47/device2022-01: 0 reports for this device; peer average 2.18/device2022-02: 0 reports for this device; peer average 2.55/device2022-03: 0 reports for this device; peer average 2.13/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 2.25/device2022-06: 0 reports for this device; peer average 2.22/device2022-07: 0 reports for this device; peer average 2.17/device2022-08: 0 reports for this device; peer average 2.25/device2022-09: 0 reports for this device; peer average 2.21/device2022-10: 0 reports for this device; peer average 2.22/device2022-11: 0 reports for this device; peer average 2.4/device2022-12: 0 reports for this device; peer average 2.35/device2023-01: 0 reports for this device; peer average 2.21/device2023-02: 0 reports for this device; peer average 2.13/device2023-03: 0 reports for this device; peer average 2.28/device2023-04: 0 reports for this device; peer average 2.21/device2023-05: 0 reports for this device; peer average 2.29/device2023-06: 0 reports for this device; peer average 2.36/device2023-07: 0 reports for this device; peer average 2.21/device2023-08: 0 reports for this device; peer average 2.09/device2023-09: 0 reports for this device; peer average 2.1/device2023-10: 0 reports for this device; peer average 1.65/device2023-11: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 1.75/device2024-01: 0 reports for this device; peer average 1.78/device2024-02: 0 reports for this device; peer average 2.03/device2024-03: 0 reports for this device; peer average 1.99/device2024-04: 0 reports for this device; peer average 1.78/device2024-05: 0 reports for this device; peer average 2.22/device2024-06: 0 reports for this device; peer average 1.93/device2024-07: 0 reports for this device; peer average 1.76/device2024-08: 0 reports for this device; peer average 1.91/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 1.8/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 0 reports for this device; peer average 1.62/device2025-01: 0 reports for this device; peer average 1.93/device2025-02: 0 reports for this device; peer average 1.57/device2025-03: 0 reports for this device; peer average 1.74/device2025-04: 0 reports for this device; peer average 1.87/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 reports for this device; peer average 1.86/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.81/device2025-09: 0 reports for this device; peer average 1.82/device2025-10: 0 reports for this device; peer average 1.79/device2025-11: 0 reports for this device; peer average 1.97/device2025-12: 0 reports for this device; peer average 1.98/device2026-01: 0 reports for this device; peer average 2.12/device2026-02: 0 reports for this device; peer average 1.77/device2026-03: 0 reports for this device; peer average 2.15/device2026-04: 0 reports for this device; peer average 1.96/device2026-05: 0 reports for this device; peer average 1.97/device2026-06: 0 reports for this device; peer average 1.77/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.95
2019-0202.6
2019-0302.76
2019-0402.65
2019-0502.1
2019-0601.86
2019-0701.9
2019-0802.15
2019-0902.27
2019-1002.43
2019-1102.08
2019-1202.47
2020-0102.82
2020-0202.53
2020-0303.22
2020-0402.35
2020-0502.47
2020-0602.01
2020-0702.53
2020-0802.05
2020-0902.54
2020-1002.66
2020-1102.28
2020-1202.3
2021-0102.32
2021-0202.09
2021-0302.11
2021-0402.05
2021-0502.13
2021-0602.42
2021-0702.49
2021-0802.28
2021-0902.51
2021-1002.25
2021-1102.3
2021-1202.47
2022-0102.18
2022-0202.55
2022-0302.13
2022-0402.3
2022-0502.25
2022-0602.22
2022-0702.17
2022-0802.25
2022-0902.21
2022-1002.22
2022-1102.4
2022-1202.35
2023-0102.21
2023-0202.13
2023-0302.28
2023-0402.21
2023-0502.29
2023-0602.36
2023-0702.21
2023-0802.09
2023-0902.1
2023-1001.65
2023-1101.67
2023-1201.75
2024-0101.78
2024-0202.03
2024-0301.99
2024-0401.78
2024-0502.22
2024-0601.93
2024-0701.76
2024-0801.91
2024-0902.07
2024-1001.8
2024-1101.79
2024-1201.62
2025-0101.93
2025-0201.57
2025-0301.74
2025-0401.87
2025-0501.75
2025-0601.86
2025-0701.81
2025-0801.81
2025-0901.82
2025-1001.79
2025-1101.97
2025-1201.98
2026-0102.12
2026-0201.77
2026-0302.15
2026-0401.96
2026-0501.97
2026-0601.77
This device (reports/month)Average device in JDI, 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

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