GENESIS II TOTAL KNEE SYSTEM— 510(k) K951987

Name: FDA 510(k) clearance K951987
Creator: U.S. Food and Drug Administration
Published: 1995-08-22

Substantially Equivalent

Smith & Nephew Richards, Inc.

FDA 510(k) clearance K951987 for GENESIS II TOTAL KNEE SYSTEM, Substantially Equivalent on 1995-08-22. Applicant: Smith & Nephew Richards, Inc.. Device class: 2.

Clearance details

Applicant: Smith & Nephew Richards, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 1995-04-27
Decision date: 1995-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
K262130 — ATTUNE Revision Knee System2026-09-04
K253961 — SK Knee System2026-09-01

More clearances from Smith & Nephew Richards, Inc.

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K965224 — EMPOWER ANTERIOR DIRECT SCREWS1997-05-08
K963509 — GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON1997-01-27
K960444 — FINN ROD TO ROD CONNECTOR1997-01-24
K964163 — TRIMAX NAIL SYSTEM1996-12-27
K962557 — GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT1996-12-05

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K951987

K-number listed on FDA's recall record

Z-1418-2022 — (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.Class II·Terminated·Smith & Nephew, Inc.·20220627
Z-2774-2020 — Tibial knee prosthesisClass II·Ongoing·Smith & Nephew, Inc.·20200716
Z-2883-2018 — GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesisClass II·Terminated·Smith & Nephew, Inc.·20170801
Z-0573-2016 — Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.Class II·Terminated·Smith & Nephew, Inc.·20151109
Z-0130-2014 — GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedicClass II·Terminated·Smith & Nephew Inc·20131007
Z-0131-2014 — GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedicClass II·Terminated·Smith & Nephew Inc·20131007

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K951987.

Data sourced from openFDA. This site is unofficial and independent of the FDA.