ARCOS INTERLOCKING DISTAL STEMS
FDA 510(k) clearance K100469 · decided 2010-12-07
Clearance details
- K-number
- K100469
- Device name
- ARCOS INTERLOCKING DISTAL STEMS
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2010-02-18
- Decision date
- 2010-12-07
- Days to decision
- 292 days
- Clearance type
- Traditional
- Product code
- KWA
- Device class
- 3
- Regulation number
- 888.3330
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROFEMUR Z REVISION HIP STEM (K122778) | Wrightmedicaltechnologyinc | 2012-10-11 |
| DYNASTY BIOFOAM SHELL (K121544) | Wrightmedicaltechnologyinc | 2012-07-30 |
| METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS (K113271) | Biomet Manufacturing, Inc. | 2012-05-18 |
| CONSERVE THIN SHELL (K113322) | Wrightmedicaltechnologyinc | 2012-02-03 |
| PRESERVE HIP STEM (K112080) | Wrightmedicaltechnologyinc | 2011-12-28 |
| PROFEMUR GLADIATOR HA HIP STEM (K112150) | Wrightmedicaltechnologyinc | 2011-11-23 |
| PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER (K113019) | Wrightmedicaltechnologyinc | 2011-11-10 |
| GLADIATOR HIP STEM (K111910) | Wrightmedicaltechnologyinc | 2011-10-14 |
| CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY (K110836) | Zimmer GmbH | 2011-10-07 |
| TAPERLOC COMPLETE MICROPLASTY STEM (K110400) | Biomet Manufacturing Corp | 2011-09-30 |
| PROFEMUR(R) E CEMENTLESS HIP STEM (K111698) | Wrightmedicaltechnologyinc | 2011-08-19 |
| PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM (K111699) | Wrightmedicaltechnologyinc | 2011-08-19 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110) | Biomet Manufacturing Corp | 2025-06-24 |
| Oxford® Partial Knee System (P010014/S107) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Cementless Partial Knee System (P010014/S105) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Partial Knee System (P010014/S108) | Biomet Manufacturing Corp | 2024-11-18 |
| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |