510(k) K240452
- Device
- Ceramic Femoral Head
- Applicant
- Microport Orthopedics, Inc.
- 510(k) number
- K240452
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-12
- Date received
- 2024-02-15
- Regulation
- 888.3353
- Classification name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Hunter Williams
- Address
- 5677 Airline Rd. Arlington TN US 38002 38002
FDA Registration Numbers
- 1423662
- 1450662
- 1000294921
- 3002807090
- 1000200989
- 3027484613
- 2242737
- 1833506
- 3004641308
- 3005180920
- 3000236920
- 2133928
- 3004493876
- 3007913880
- 1000547811
- 3009241418
- 3013176080
- 3002807315
- 3021008900
- 3007334927
- 3010386387
- 3010057495
- 3006801265
- 3014252644
- 1835831
- 3009871135
- 2183744
- 3016778562
- 3012275107
- 8044172
- 1644408
- 3023852420
- 1834331
- 3003541440
- 1226188
- 1018470
- 3010287737
- 3000264985
- 3013194153
- 3013791180
- 3005323511
- 1833920
- 1827096
- 3006809628
- 3002807112
- 3009760038
- 3025603301
- 3003595343
- 3030338875
- 3005061536
- 2032521
- 3014170143
- 3010163695
- 3034676720
- 1643264
- 3004142400
- 3006946279
- 3026771806
- 1043653
- 1219655
- 9610612
- 2246552
- 3009106092
- 3014763043
- 2648920
- 3007740680
- 3002806535
- 1721676
- 3015516266
- 3009475821
- 3010041693
- 3012916784
- 3006395932
- 1218882
- 3004635447
- 1064858
- 3002807314
- 3004153896
- 3009756327
Source Documents
Other 510(k) Records For Product Code LZO
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260182 | Avenir® Müller Stem; Avenir Complete Hip System | Zimmer, Inc. | 2026-04-27 |
| K260037 | implantcast Packaging System Update | Implantcast GmbH | 2026-03-30 |
| K252401 | implaFit® short stems | Implantcast GmbH | 2026-03-12 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | 2026-01-15 |
| K250450 | Coated hip implants | Medacta International S.A. | 2025-09-19 |
| K243021 | Longboard Revision Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-08-07 |
| K251906 | Z1 Hip System | Zimmer, Inc. | 2025-07-18 |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025-05-23 |
| K243927 | MobileLink Acetabular Cup System - inhouse coatings | Waldemar Link GmbH & Co. KG | 2025-05-16 |
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 |
| K243043 | Origin Cemented Hip Stem | Signature Orthopaedics Pty, Ltd. | 2025-05-02 |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter) | Zimmer Biomet | 2025-04-18 |
| K250571 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | 2025-03-28 |
| K243029 | Origin TT Stem | Signature Orthopaedics Pty, Ltd. | 2025-03-11 |
| K241767 | Versacem Acetabular Shell and Double Mobility HC Liners | Medacta International S.A. | 2025-03-06 |