Panels › Orthopedic › Product code LZY · Class 2
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Regulation 888.3360
0510(k)s in 12 months (8 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in LZY
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 1 | 1 |
| Biomet, Inc. | 1 | 0 |
| BioPro, Inc. | 0 | 1 |
| Depuy, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 0 | 1 |
| Implantology Corp. | 1 | 0 |
| Medacta International | 1 | 0 |
| P.T. Latexindo Tobaperkasa | 1 | 0 |
| Protek, Inc. | 1 | 0 |
| Richards Medical Co., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. BioPro Endo Head (Ceramic)
Product ID/Description
13006 ENDO MODULAR CERAMIC SH 38
13012 ENDO MODULAR CERAMIC SH 51
13013 ENDO MODULAR CERAMIC MD 38
13019 ENDO MODULAR CERAMIC MD 51
13007 ENDO MODULA Open, Classified |
LZY | K954768 |
| May 18, 2022 | DePuy Orthopaedics, Inc. MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348 Open, Classified |
LZY | K903084 |
| Sep 24, 2009 | Smith & Nephew Inc Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116
Designed for use with femoral stems and acetabular
components distributed by Smith & Nephew. Terminated |
LZY | K030766 |
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