# K983452: Nelson Resurfacing Head

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 3, 1998 after 64 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
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Converse: named in the summary without a submission number
- (no number) Ceramic TARA Femoral Resurfacing Component: named in the summary without a submission number
- (no number) Tharies: named in the summary without a submission number

## Most influential descendants
- K021799: Cemented Femoral Head Resurfing Device (2002), 9 descendants of its own
- K023188: Press-Fit Head Resurfacing Device (2002), 7 descendants of its own
- K082673: Conserve Pressfit Femoral Component (2008), 2 descendants of its own
- K032659: Depuy Asr Resurfacing Femoral Heads (2003), 2 descendants of its own
- K173898: MicroPort Orthopedics Total Hip Systems MR Labeling (2018), 1 descendant of its own

## Indications for use
a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis b.) rheumatoid arthritis The Nelson Resurfacing Head is cemented femoral component and is a single use implant.

Source page: https://510kreport.com/device/K983452
Methodology: https://510kreport.com/methodology