NJD

Product Code: NJD

Products Classified as NJD

4643

Prosthesis, Knee, Femorotibial, Semi-constrained, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer

Knee Joint Femorotibial (uni-compartmental) Metal/polymer Porous-coated Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4643

Prosthesis, Knee, Femorotibial, Semi-constrained, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer

Knee Joint Femorotibial (uni-compartmental) Metal/polymer Porous-coated Uncemented Prosthesis.

FDA Consensus Standards

• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [34059]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [38231]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [37410]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [37411]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [35610]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [31877]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [33508]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [32210]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [32380]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [37470]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [33509]: 21 CFR §888.3535 🔎
• Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer [33949]: 21 CFR §888.3535 🔎

Pre-market Notifications for NJD

K222653	JOURNEY II UK™ And ENGAGE™ Cementless Partial Knee System	Smith+Nephew, Inc
K190439	Engage™ Partial Knee System	Engage UNI, LLC
K133811	RESTORIS POROUS PARTIAL KNEE SYSTEM	MAKO SURGICAL CORP.

Global Unique Device Identification Database

• 00848486016593: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016548: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016456: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016449: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016432: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016364: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016265: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016258: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016234: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016227: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016203: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016180: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016166: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016135: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER
• 00848486016128: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, UNICOMPARTMENTAL/UNICONDYLAR, UNCEMENTED, POROUS-COATED, METAL/POLYMER

Maude Adverse Events

PINN CAN BONE SCREW 6.5MMX20MM	DEPUY-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC.	2010-04-09
PINN CAN BONE SCREW 6.5MMX30MM	DEPUY ORTHOPAEDICS, INC.	2010-04-08