# K962448: Primaloc Cemented Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Development Corp.
- Decided: Sep 19, 1996 after 87 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Impact One-Piece Implant: named in the summary without a submission number
- (no number) S-ROM OPC I Hip Stem for Cement: named in the summary without a submission number
- (no number) Perfecta: named in the summary without a submission number

## Recalls of this device
- Jul 28, 2010 · Not classified · Z-0315-2011: The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
- Dec 26, 2002 · Not classified · Z-0568-03: Cleaning agent residue from packaging material was adhering to implantable hip stems.

## Indications for use
The Primaloc™ Cemented Hip System is intended for single, cemented use during primary or revision arthroplasty surgery. Indications include: (1) Osteoarthritis or rheumatoid arthritis, or other osteoarthroses of the hip joint; (2) Certain femoral neck fractures; (3) Idiopathic avascular necrosis; (4) Post traumatic arthritis; (5) Benign or malignant bone tumors where sufficient bone stock is present to seat the prosthesis; (6) Previously failed implant.

Source page: https://510kreport.com/device/K962448
Methodology: https://510kreport.com/methodology