FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional
K Number: K231873
·
Decision Jan 19, 2024
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
48
Review Days
207
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Basic Information
- Device Name
- DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional
- K Number
- K231873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Ireland UC
- Date Received
- June 26, 2023
- Decision Date
- January 19, 2024
- Product Code
- MEH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | FDA class 2 | Orthopedic |
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| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | Nov 19, 2025 | Substantially Equivalent |
| K251292 | RECLAIM Monobloc Revision Femoral Stem | May 23, 2025 | Substantially Equivalent |
| K243977 | EMPHASYS Acetabular System | Jan 22, 2025 | Substantially Equivalent |
| K243248 | INHANCE INTACT | Dec 23, 2024 | Substantially Equivalent |
| K242871 | ATTUNE Revision Hinge Knee | Nov 21, 2024 | Substantially Equivalent |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HA | Oct 7, 2024 | Substantially Equivalent |
| K241000 | ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System; | Jul 11, 2024 | Substantially Equivalent |