# K023188: Press-Fit Head Resurfacing Device

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Dec 11, 2002 after 78 days
- Product code: KXA (Prosthesis, Hip, Femoral, Resurfacing)
- Device class: 2
- Regulation: 21 CFR 888.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983452 (1998). 3 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021799: Cemented Femoral Head Resurfing Device, Biomet Orthopedics, Inc. (2002) Summary page 1.
- K811718: Surface Replacement Hip Prosthesis, Biomet, Inc. (1981) Summary page 1.

## Cited in the summary but kept off the family tree
- K811008: Conserve Head. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.
- K962514: TARA Head. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K082673: Conserve Pressfit Femoral Component (2008), 2 descendants of its own
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own
- K071053: Recap HA Press-Fit Femoral Resurfacing Head (2007), 1 descendant of its own
- K043542: Biopro Tara Femoral Resurfacing Component (2005), 1 descendant of its own
- K240452: Ceramic Femoral Head (2024), 0 descendants of its own

## Indications for use
Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

Source page: https://510kreport.com/device/K023188
Methodology: https://510kreport.com/methodology