# K981211: Apr -T Revision Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: May 22, 1998 after 50 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) APR® Collared Revision Stem: named in the summary without a submission number
- (no number) APR® Porous Hip Stem: named in the summary without a submission number
- (no number) BIAS™ Total Hip Prosthesis: named in the summary without a submission number
- (no number) PCA™ Long Stem: named in the summary without a submission number
- (no number) Natural-Hip™ Porous Stem: named in the summary without a submission number

## Most influential descendants
- K112897: Renovis Surgical Hip Joint Replacement Prosthesis (2012), 8 descendants of its own
- K132312: Renovis Tesera Trabecular Technology (T3) Acetabular Shell System (2014), 6 descendants of its own
- K141676: Renovis Surgical Porous Acetabular Cup System (2014), 4 descendants of its own
- K200328: Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System (2020), 1 descendant of its own
- K143647: Renovis Surgical Hip Replacement System (2015), 1 descendant of its own

## Indications for use
The APR-T Revision Hip Stem is intended for prosthetic replacement of the proximal portion of the femur during hip arthroplasty. This hip stem can be used for total hip replacements (i.e., replacements where both the femur and acetabulum are replaced) or for hemi-arthroplasties where the hip stem-head assembly articulates directly with well-preserved articular cartilage. For this indication, the stem must be paired with one of the following Sulzcr Orthopedics endoprosthesis: e the Unipolar with 12/14 Taper, cleared for use via 510(k)s K833403 and K934159, or e the Bipolar component which was cleared for use via 510(k)s K833404 and K873815 and is indicated for use with a CoCr modular femoral head. Specific diagnostic indications include: 1. Patient conditions of inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis); 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persist; and, 3. Revision of previously failed hip arthroplasty. The APR-T Revision Hip Stem is iniended for use with or without bone cement.

Source page: https://510kreport.com/device/K981211
Methodology: https://510kreport.com/methodology