# K201157: Prime BIOFOAM® Multi-Hole Shells

- Pathway: 510(k) (Traditional)
- Applicant: Microport Orthopedics, Inc.
- Decided: Aug 24, 2021 after 481 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- 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: 7 generations back to K930712 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170444: PROCOTYL® PRIME Acetabular Cup System, Microport Orthopedics, Inc. (2017) Summary page 4.
- K122382: Dynasty Biofoam Shell, Wrightmedicaltechnologyinc (2012) Summary page 4.
- K082924: Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner, Wrightmedicaltechnologyinc (2009) Summary page 4.

## Indications for use
The Prime Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use 1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2) inflammatory degenerative joint disease such as rheumatoid arthritis; 3) correction of functional deformity; and, 4) revision procedures where other treatments or devices have failed. Shells with BIOFOAM® coating are intended only for uncemented arthroplasty.

Source page: https://510kreport.com/device/K201157
Methodology: https://510kreport.com/methodology