# K091423: Profemur Hip System Modular Necks

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Aug 25, 2009 after 104 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
36 later devices descend from it; 9 cite it directly.
2 of 37 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 no predicate by number.

## Most influential descendants
- K100866: Profemur Hip System Modular Necks (2010), 14 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K112080: Preserve Hip Stem (2011), 8 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own
- K111910: Gladiator Hip Stem (2011), 5 descendants of its own

## Recalls of this device
- Jul 31, 2020 · Class II · Z-2948-2020: MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip Syst
- Aug 4, 2015 · Class I · Z-2743-2015: Unexpected rate of postoperative fractures resulting in the need for revision surgery.

## Indications for use
The PROFEMUR® Hip System Modular Necks are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammato1y degenerative joint disease such as osteoartlhitis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.

Source page: https://510kreport.com/device/K091423
Methodology: https://510kreport.com/methodology