# K982812: G2 Total Hip System Femoral Stem (11/13 Taper)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Dec 4, 1998 after 115 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850055 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964769: Versys Hip System--Fiber Metal Taper Hip Prosthesis, Zimmer, Inc. (1997) Summary page 2.
- K963109: Heritage Hip System, Zimmer, Inc. (1997) Summary page 2.
- K933570: Resolution (TM) Hip Stem, Wrightmedicaltechnologyinc (1994) Summary page 2.
- K944592: Precision Osteolock Femoral Component, Howmedica Corp. (1995) Summary page 2.
- K945518: P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component, Johnson & Johnson Professionals, Inc. (1996) Summary page 2.
- K963885: Ultima FX Femoral Hip Stems, Johnson & Johnson Professionals, Inc. (1996) Summary page 2.
- K972435: Ultima and Ultima LX Cemented Femoral Stem, Johnson & Johnson Professionals, Inc. (1997) Summary page 2.
- K924379: Ultima (TM) Total Hip System Cemented Femoral Stem, Johnson & Johnson Orthopaedics, Inc. (1993) Summary page 2.

## Indications for use
The G2 Total Hip System Femoral Stems (11/13 Taper) are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatiod arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenial hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques. The G2 Polished Femoral Stem (11/13 taper) is indicated for use only with PMMA bone cement. The G2 Microtextured Femoral Stem (11/13 taper) is not indicated for use with PMMA bone cement.

Source page: https://510kreport.com/device/K982812
Methodology: https://510kreport.com/methodology