FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Trivicta® Hip Stem
K Number: K251052
·
Decision May 22, 2025
Classifications
1
FEI Numbers
189
Registration Numbers
189
Same Product Code
158
Applicant Total
45
Review Days
49
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Basic Information
- Device Name
- Trivicta® Hip Stem
- K Number
- K251052
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Development Corp.
- Date Received
- April 3, 2025
- Decision Date
- May 22, 2025
- 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 |
Similar 510(k) Clearances
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Other Clearances by Ortho Development Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Dec 19, 2025 | Substantially Equivalent |
| K242984 | BKS Revision System | Oct 25, 2024 | Substantially Equivalent |
| K242833 | Legend® Acetabular Shell | Oct 11, 2024 | Substantially Equivalent |
| K233758 | Trivicta Hip Stem | Mar 8, 2024 | Substantially Equivalent |
| K142146 | IBIS PEDICLE SCREW SYSTEM | Dec 11, 2014 | Substantially Equivalent |
| K132697 | ENCOMPASS 10/12 HIP STEM | Jun 20, 2014 | Substantially Equivalent |
| K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM | Mar 11, 2014 | Substantially Equivalent |
| K133449 | KASM KNEE ARTICULATING SPACER MOLDS | Feb 18, 2014 | Substantially Equivalent |
| K131022 | OVATION 10/12 HIP STEM | Oct 16, 2013 | Substantially Equivalent |
| K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA | Oct 11, 2013 | Substantially Equivalent |