# K994184: PLR Splined Revision Stem

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 15, 2000 after 67 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871347 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960588: Wagner Revision Stem, Intermedics Orthopedics (1996) Summary page 2.
- K871347: Wagner Revisional Femoral Hip Prosthesis, Protek, Inc. (1987) Summary page 2.

## Indications for use
The PLR Splined Revision Stems is indicated for use in patients requiring total reconstruction of the hip joint due to the following: a.) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. b.) Rheumatoid arthritis. c.) Correction of functional deformity. d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. e.) Revision of previously failed total hip arthroplasty due to recurrent dislocations. The PLR Splined Revision Stem is intended for press-fit application for general use in skeletally mature individuals undergoing surgery for rehabilitating hip joints. This device is a single use implant

Source page: https://510kreport.com/device/K994184
Methodology: https://510kreport.com/methodology