# K990197: Modulus Compatible Stability (MCS)-HA Total Hip System

- Pathway: 510(k) (Special)
- Applicant: Exactech, Inc.
- Decided: Feb 4, 1999 after 15 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
164 later devices descend from it; 5 cite it directly.
0 of 165 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) Exactech MCS Total Hip System: named in the summary without a submission number
- (no number) Charnley: named in the summary without a submission number
- (no number) Zimmer Harris-Galante: named in the summary without a submission number
- (no number) Depuy AML: named in the summary without a submission number
- (no number) Osteonics Secur-Fit HA: named in the summary without a submission number
- (no number) Smith & Nephew Synergy HA: named in the summary without a submission number
- (no number) OTI: named in the summary without a submission number

## Most influential descendants
- K993082: Exactech Acumatch Integrated Hip System a-Series Porous Coated Acetabular Component (1999), 161 descendants of its own
- K002141: Acumatch P-Series Press-Fit Plasma, Acumatch P-Series Press-Fit, Acumatch L-Series Press-Fit (2000), 147 descendants of its own
- K030236: Acumatch P-Series Porous Press-Fit Femoral Component (2003), 146 descendants of its own
- K041906: Exactech 12/14 Total Hip System (2004), 145 descendants of its own
- K042842: Novation 12/14 Press-Fit Femoral Stem (2004), 64 descendants of its own

## Indications for use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis. ankylosing spondylitis, congenital hip dysplasia, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Exactech Hip Systems are also potentially indicated for revision of failed previous reconstruction’s where sufficient bone stock is present.

Source page: https://510kreport.com/device/K990197
Methodology: https://510kreport.com/methodology