FDA product code LZY: Prosthesis, Hip, Hemi-, Femoral, Metal Ball
LZY is the FDA product code for prosthesis, hip, hemi-, femoral, metal ball. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel. FDA has cleared 8 510(k) submissions under LZY, 1 in the last five years, from 8 different applicants. The average 510(k) review took 145 days (median 90). FDA has posted 3 recalls for LZY devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| Device class | Class II |
| Regulation | 21 CFR 888.3360 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for LZY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 62 |
Compare with all 510(k) review times · Search every LZY clearance
Top LZY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 1 | 2023-07-19 |
| Medacta International | 1 | 2011-08-16 |
| P.T. Latexindo Tobaperkasa | 1 | 1998-01-05 |
| Implantology Corp. | 1 | 1993-06-29 |
| Biomet, Inc. | 1 | 1992-03-10 |
3 more applicants have LZY clearances. See the full list in Caduvo.
Most recent LZY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231448 | Smith & Nephew, Inc. | TANDEM Hip System | 2023-07-19 | 62 |
| K111145 | Medacta International | ENDO HEAD | 2011-08-16 | 116 |
| K974442 | P.T. Latexindo Tobaperkasa | PRE-POWDERED NITRILE EXAMINATION GLOVES | 1998-01-05 | 41 |
| K915528 | Implantology Corp. | BHR BIPOLAR FEMORAL HEAD COMPONENT | 1993-06-29 | 567 |
| K915548 | Biomet, Inc. | IONGUARD TITANIUM MODULAR HEADS | 1992-03-10 | 90 |
Recalls for LZY devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-09-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LZY?
LZY is the FDA product code for prosthesis, hip, hemi-, femoral, metal ball. It is a Class II device, regulated under 21 CFR 888.3360 and reviewed by the Orthopedic panel.
What device class is LZY?
Class II, regulation 21 CFR 888.3360. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZY?
Across 8 cleared submissions the average was 145 days from receipt to decision (median 90).
Which companies have the most LZY clearances?
Smith & Nephew, Inc. (1); Medacta International (1); P.T. Latexindo Tobaperkasa (1); Implantology Corp. (1); Biomet, Inc. (1).
Have LZY devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-09-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LZY
- Run a recall and safety report across every LZY manufacturer
- Watch product code LZY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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