# K191374: Revival Modular Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Corin U.S.A. Limited
- Decided: Jul 22, 2019 after 60 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: 9 generations back to K921308 (1994). 70 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 74 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152903: REVIVAL (TM) Modular Revision Hip Stem, Corin USA (2016) Summary page 4.
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads, Lima Corporate S.P.A. (2012) Summary page 4.

## Most influential descendants
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own
- K261576: Icona Hip Stem (2026), 0 descendants of its own

## Indications for use
The Revival™ Modular Hip Stem is indicated in revision surgery of femoral components, following failure of a primary cemented or un-cemented prosthesis. The Revival™ Modular Hip Stem 100mm distal component is also indicated in primary total hip arthroplasty. The indications for the Revival™ Modular Hip Stem include: Non-inflammatory degenerative joint disease including primary and secondary osteoarthritis and hip dysplasia Aseptic necrosis of the femoral head Rheumatoid arthritis Correction of functional deformity Treatment of non-union and femoral neck fractures Treatment of traumatic dislocations of the hip Failures of osteotomy Treatment of arthrodesis The Revival™ Modular Hip Stem is indicated for cementless, single use only.

Source page: https://510kreport.com/device/K191374
Methodology: https://510kreport.com/methodology