Klassic HD Acetabular Insert with E-Link Poly
FDA 510(k) K141972 · Total Joint Orthopedics, Inc.
Submission
- Device name
- Klassic HD Acetabular Insert with E-Link Poly
- Applicant
- Total Joint Orthopedics, Inc.
Salt Lake City, UT, US - Received
- July 21, 2014
- Decision date
- October 9, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…JWH · Special | 03/15/2019SE |
| K180929 | Klassic HD® Hip SystemLZO · Special | 05/09/2018SE |
| K180159 | Klassic® Knee SystemJWH · Traditional | 03/09/2018SE |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…OQG · Special | 10/27/2017SE |
Questions and answers
When was Klassic HD Acetabular Insert with E-Link Poly cleared by the FDA?
Klassic HD Acetabular Insert with E-Link Poly (K141972) received a 510(k) decision of Substantially Equivalent on October 9, 2014, 80 days after the submission was received.
What is the product code of K141972?
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.