Legion Inserts With JRNY Lock

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Legion Inserts With Jrny Lock.

Pre-market Notification Details

• Device ID: K220896
• 510k Number: K220896
• Device Name: Legion Inserts With JRNY Lock
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Contact: Madison Padgett
• Correspondent: Madison Padgett; Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-03-28
• Decision Date: 2022-04-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556797501	K220896	000
00885556797341	K220896	000
00885556797334	K220896	000
00885556797327	K220896	000
00885556797310	K220896	000
00885556797303	K220896	000
00885556797297	K220896	000
00885556797280	K220896	000
00885556797273	K220896	000
00885556797266	K220896	000
00885556797259	K220896	000
00885556797242	K220896	000
00885556797235	K220896	000
00885556797358	K220896	000
00885556797365	K220896	000
00885556797372	K220896	000
00885556797495	K220896	000
00885556797488	K220896	000
00885556797471	K220896	000
00885556797464	K220896	000
00885556797457	K220896	000
00885556797440	K220896	000
00885556797433	K220896	000
00885556797426	K220896	000
00885556797419	K220896	000
00885556797402	K220896	000
00885556797396	K220896	000
00885556797389	K220896	000
00885556797228	K220896	000
00885556797211	K220896	000
00885556790595	K220896	000
00885556790588	K220896	000
00885556790564	K220896	000
00885556790557	K220896	000
00885556790540	K220896	000
00885556790533	K220896	000
00885556790526	K220896	000
00885556790502	K220896	000
00885556790496	K220896	000
00885556790489	K220896	000
00885556790472	K220896	000
00885556790465	K220896	000
00885556790601	K220896	000
00885556790618	K220896	000
00885556790625	K220896	000
00885556797204	K220896	000
00885556797198	K220896	000
00885556797181	K220896	000
00885556797174	K220896	000
00885556797167	K220896	000
00885556797150	K220896	000
00885556797143	K220896	000
00885556790687	K220896	000
00885556790670	K220896	000
00885556790663	K220896	000
00885556790656	K220896	000
00885556790649	K220896	000
00885556900215	K220896	000
00885556797518	K220896	000
00885556817933	K220896	000
00885556797938	K220896	000
00885556797921	K220896	000
00885556797914	K220896	000
00885556797907	K220896	000
00885556797891	K220896	000
00885556797884	K220896	000
00885556797877	K220896	000
00885556797860	K220896	000
00885556797853	K220896	000
00885556797846	K220896	000
00885556797839	K220896	000
00885556797822	K220896	000
00885556797945	K220896	000
00885556797952	K220896	000
00885556797969	K220896	000
00885556817926	K220896	000
00885556817919	K220896	000
00885556817902	K220896	000
00885556817896	K220896	000
00885556817889	K220896	000
00885556817872	K220896	000
00885556817865	K220896	000
00885556798010	K220896	000
00885556798003	K220896	000
00885556797990	K220896	000
00885556797983	K220896	000
00885556797976	K220896	000
00885556797815	K220896	000
00885556797808	K220896	000
00885556797648	K220896	000
00885556797631	K220896	000
00885556797624	K220896	000
00885556797617	K220896	000
00885556797600	K220896	000
00885556797594	K220896	000
00885556797587	K220896	000
00885556797570	K220896	000
00885556797563	K220896	000
00885556797556	K220896	000
00885556797549	K220896	000
00885556797532	K220896	000
00885556797655	K220896	000
00885556797662	K220896	000
00885556797679	K220896	000
00885556797792	K220896	000
00885556797785	K220896	000
00885556797778	K220896	000
00885556797761	K220896	000
00885556797754	K220896	000
00885556797747	K220896	000
00885556797730	K220896	000
00885556797723	K220896	000
00885556797716	K220896	000
00885556797709	K220896	000
00885556797693	K220896	000
00885556797686	K220896	000
00885556797525	K220896	000