510(k) K241483
- Device
- ceramys™ femoral head system
- Applicant
- Encore Medical L.P.
- 510(k) number
- K241483
- Product code
- LZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-07
- Date received
- 2024-05-24
- 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
Applicant Contact#
- Contact
- Katrina Dombovari
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3008812251
- 9615674
- 3007923096
- 3010386387
- 3043543260
- 3013194153
- 3007740680
- 3015516266
- 3010120135
- 3004748528
- 1721676
- 1722511
- 3011274144
- 9617840
- 1020279
- 3005061536
- 3009760038
- 1219655
- 1423662
- 3008395353
- 1835572
- 3010097171
- 3011170410
- 1835251
- 3011683674
- 3003541440
- 2246552
- 3006946279
- 9615800
- 3020155054
- 3012130008
- 3023852420
- 1833920
- 1835831
- 3010155661
- 3010163695
- 3014302784
- 3002807310
- 3001278222
- 3003595343
- 1424263
- 3036795922
- 3015398319
- 2244478
- 3010220595
- 3010041693
- 1226188
- 3005180920
- 3005360851
- 3005551626
- 3006017180
- 2134285
- 3008102042
- 3012119238
- 3004153896
- 3007200272
- 3002807090
- 3002807314
- 3009173317
- 1057425
- 3030412764
- 3006536454
- 1531174
- 3016438761
- 2032521
- 3005323511
- 9614209
- 3042508254
- 3005333358
- 1643817
- 9616671
- 3003761012
- 3002806603
- 3002808022
- 3031800723
- 3010009693
- 3003998208
- 3015259876
- 2245304
Source Documents#
Other 510(k) Records For Product Code LZO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026-09-17 |
| K253948 | Momentum Acetabular Cup System | United Orthopedic Corporation | 2026-09-02 |
| K261009 | MobileLink Acetabular Cup System – 40mm ID Inserts (various) | Waldemar Link GmbH & Co. KG | 2026-07-06 |
| K260831 | Z1 Hip System | Zimmer, Inc. | 2026-06-16 |
| 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 |