# K213816: MPO Hip Instruments

- Pathway: 510(k) (Special)
- Applicant: Microport Orthopedics, Inc.
- Decided: Jan 5, 2022 after 29 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K930712 (1993). 56 ancestors in all.
No later device cites it as a predicate yet.
2 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140676: Profemur TL Classic Long Neck Hip Stems, Microport Orthopedics, Inc. (2014) Summary page 4.
- K141235: Profemur Renaissance Classic Long Neck Hip Stems, Microport Orthopedics, Inc. (2014) Summary page 4.
- K150133: PROFEMUR Preserve Size 1-3 Hip Stems, Microport Orthopedics, Inc. (2015) Summary page 4.
- K150302: PROFEMUR Preserve Classic Stem, Microport Orthopedics, Inc. (2015) Summary page 5.
- K170444: PROCOTYL® PRIME Acetabular Cup System, Microport Orthopedics, Inc. (2017) Summary page 5.
- K190123: MicroPort CoCr Femoral Heads, Microport Orthopedics, Inc. (2019) Summary page 5.
- K191632: PROFEMUR TL2 Stems, Microport Orthopedics, Inc. (2019) Summary page 5.
- K201519: PROFEMUR® GLADIATOR® Cemented Classic Stem, Microport Orthopedics, Inc. (2020) Summary page 5.

## Indications for use
MicroPort hip instruments are accessory devices and are intended to be used to assist in the implantation of MicroPort Hip Systems in their cleared indications for use. MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients: 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 Rough grit blast surfaces and the hydroxyapatite and titanium plasma spray coatings applied to implant surfaces are intended for uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty. LINEAGE® and DYNASTY® modular shells with porous metal bead coating are intended only for uncemented arthroplasty. PRIME shells are intended only for uncemented arthroplasty.

Source page: https://510kreport.com/device/K213816
Methodology: https://510kreport.com/methodology