# K982367: Reach Hip Component

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 24, 1998 after 48 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
Longest line of descent: 1 generation back to K921225 (1994). 5 ancestors in all.
209 later devices descend from it; 2 cite it directly.
0 of 215 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933942: Solution Bowed Femoral Hip Protsthesis, Depuy, Inc. (1994) Summary page 2.
- K941942: Solution Hip, Depuy, Inc. (1994) Summary page 2.
- K953703: Depuy Vision Solution Hip Prosthesis, Depuy, Inc. (1996) Summary page 2.
- K921225: Integral Total Hip System, Biomet, Inc. (1994). Our OCR of the scanned summary read K921255, FDA’s number for Philips BV26 Mobile C-Arm Stand (Philips Medical Systems, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Integral® Total Hip system”.
- K973302: Foundation Porous Hip Stem, Encore Orthopedics, Inc. (1997) Summary page 2.

## Most influential descendants
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components (2003), 208 descendants of its own
- K043537: Taperloc 12/14 Taper Femoral Components (2005), 160 descendants of its own
- K050124: Porous Coated Acetabular Components (2005), 138 descendants of its own
- K070369: Regenerx Ringloc + Modular Acetabular Shells (2007), 137 descendants of its own
- K093235: Ringloc + Hybrid Acetabular System (2010), 65 descendants of its own

## Indications for use
The indications for use of the Reach Femoral Component are: a.) non-inflammatory degenerative disease b.) osteoarthritis c.) avascular necrosis d.) rheumatoid arthritis e.) revisions of hip replacement components f.) treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement. The Reach stem is intended for press-fit application and for single use implantation.

Source page: https://510kreport.com/device/K982367
Methodology: https://510kreport.com/methodology