# K021970: The Trabecular Metal Monoblock Cup, Models 00-7259-0XX-28 (Zimmer Cat. #) and 02-293-28XX1 (Implex Part #)

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Jul 12, 2002 after 25 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 K964509 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964509: Implex a-240 Hep Acetabular Cup System, Implex Corp. (1997) Summary page 1.
- K003181: Implex Continuum Hip System Acetabular Components - Model XX-Yyy-ZZZZ, Implex Corp. (2000)

## Indications for use
The use of the Implex Hip System is indicated for: a) Severely disabled joints as a result of degenerative arthritis or avascular necrosis, b) Secondary revision of a previously unsuccessful femoral component or total hip replacement, c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results, d) Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be achieved, e) Non-union or femoral neck or head fractures, f) Salvage of a failed primary or secondary total or hemi hip.

Source page: https://510kreport.com/device/K021970
Methodology: https://510kreport.com/methodology