# K980020: Activelock Modular Femoral Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Metagen, LLC
- Decided: Apr 3, 1998 after 88 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 K851422 (1985). 7 ancestors in all.
2 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)
- K942027: Impact CO-CR 1-Piece Femoral Component, Biomet, Inc. (1994) Summary page 2.
- K921181: Mallory-Head Total Hip System, Biomet, Inc. (1994) Summary page 2.
- K851422: S-Rom 135 Femoral Stem & Collar (Part of S-Rom Hip, Joint Medical Products Corp. (1985) Summary page 2.
- K912713: S-Rom ZT HA Proximal Femoral Sleeve, Joint Medical Products Corp. (1991) Summary page 2.
- K913231: S-Rom (TM) Total Lhip System W/Ceramic Head, Joint Medical Products Corp. (1991) Summary page 2.
- K942115: Infinity Revision Hip Stem, Wrightmedicaltechnologyinc (1994) Summary page 2.
- K912593: Modular Hip System, Smith & Nephew Richards, Inc. (1991) Summary page 2.

## Most influential descendants
- K992815: The Margron Hip Replacement System (2000), 1 descendant of its own
- K032641: Modification to: the Margron Hip Replacement System (2004), 0 descendants of its own

## Indications for use
The ActiveLock™ Modular Femoral Hip System is intended for primary or revision reconstruction, with or without bone cement, of the femoral portion of severely disabled and/or very painful hip joint, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis; 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K980020
Methodology: https://510kreport.com/methodology