# K991807: Titanium Low Profile Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 8, 1999 after 43 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934765 (1994). 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)
- K934765: Trilogy Acetabular System, Zimmer, Inc. (1994) Summary page 1.
- K955511: Arthopor I & II Acetabular Cup/Arthopor II Oblong  Acetabular Cup, Joint Medical Products Corp. (1996) Summary page 1.

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0621-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Mar 10, 2011 · Not classified · Z-2135-2011: One lot of 30 mm screws was switched with one lot of 25 mm screws.

## Indications for use
Total hip replacement procedures for: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Correction of functional deformity 4) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 5) Revision procedures where other treatments have failed The devices are single use implants.

Source page: https://510kreport.com/device/K991807
Methodology: https://510kreport.com/methodology