# K031841: Spacer G Temporary Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Exactech, Inc.
- Decided: Jan 22, 2004 after 220 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- 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 K974807 (1998). 1 ancestor in all.
32 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974807: Osteo Austin Moore Endoprosthesis System, Osteonics Corp. (1998) Summary page 2.

## Most influential descendants
- K052990: Stageone Disposable Cement Spacer Mold for Temporary Hip Prosthesis with Reinforcement Stem (2005), 30 descendants of its own
- K062273: Spacer-G Temporary Hip Prosthesis (2008), 20 descendants of its own
- K101356: Spacer-G and Spacer-K (2011), 19 descendants of its own
- K112470: 2GC Hip/Knee Modular Spacer (2012), 16 descendants of its own
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (2019), 5 descendants of its own

## Indications for use
Spacer-G is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). Spacer-G is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).

Source page: https://510kreport.com/device/K031841
Methodology: https://510kreport.com/methodology