# K943230: Mayo Hip Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Mayo Clinic
- Decided: Jan 14, 1997 after 923 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
No predicates in its family tree.
318 later devices descend from it; 4 cite it directly.
0 of 319 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) Zimmer® Anatomic Hip System: named in the summary without a submission number
- (no number) HG MultiLock™ Hip Prosthesis: named in the summary without a submission number
- (no number) BIAS™ Total Hip System: named in the summary without a submission number

## Most influential descendants
- K030733: Mayo Conservative Hip Prosthesis, Model 8026 Series (2003), 296 descendants of its own
- K040191: Bicontact Hip Stem and Femoral Head (2004), 267 descendants of its own
- K042344: Excia Total Hip System (2005), 198 descendants of its own
- K043079: Bicontact Hip System with U-Cap (2004), 166 descendants of its own
- K093472: Trinity Acetabular System (2010), 117 descendants of its own

## Indications for use
The MAYO Hip is used in total hip arthroplasty, a surgical procedure restricted to patients with substantial pain or marked functional disabilities in which conservative treatment has not provided acceptable relief and who are not candidates for other less aggressive forms of surgery. This hip is indicated for noncemented use in skeletally mature individuals. Diagnostic indications include severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, slipped capital femoral epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Source page: https://510kreport.com/device/K943230
Methodology: https://510kreport.com/methodology