KMTI Hip Replacement System
FDA 510(k) K203472 · Kyocera Medical Technologies, Inc.
Submission
- Device name
- KMTI Hip Replacement System
- Applicant
- Kyocera Medical Technologies, Inc.
Redlands, CA, US - Received
- November 25, 2020
- Decision date
- April 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and…
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| K140701 | Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugOQG · Traditional | Novosource, Inc. | 06/27/2014SE |
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Questions and answers
When was KMTI Hip Replacement System cleared by the FDA?
KMTI Hip Replacement System (K203472) received a 510(k) decision of Substantially Equivalent on April 2, 2021, 128 days after the submission was received.
What is the product code of K203472?
The FDA product code is OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.