# Microport Orthopedics, Inc.

- Location (FDA's records): Arlington, TN
- FDA decisions: 42 (2003–2026): 40 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Microport Orthopedics, Inc. (41); Microport Orthopedics (1)
- Product codes: LZO (13), MBH (8), JWH (6), LPH (6), JDI (2), KRO (2), MRA (1), NXT (1), MBL (1), HRY (1), OQG (1)
- 510(k) review time since 2016: median 110 days, against 115 for FDA's reviews in the same codes and years (12 of 27 faster)
- Predicates its devices cite: 170 (56 its own); citations of its devices by later devices: 66 (56 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 82 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Orthomet, Inc.: 9 (https://510kreport.com/company/orthomet)
- Dow Corning Wright: 9 (https://510kreport.com/company/dow-corning-wright)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)
- DePuy Orthopaedics, Inc.: 2 (https://510kreport.com/company/depuy-orthopaedics)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Depuy (Ireland): 1 (https://510kreport.com/company/depuy-ireland)
- Signature Orthopaedics Pty, Ltd.: 1 (https://510kreport.com/company/signature-orthopaedics)

## Firms that cite its devices most
- Microport Orthopedics Inc. (Mpo): 8 (https://510kreport.com/company/microport-orthopedics-mpo)
- Implantcast GmbH: 2 (https://510kreport.com/company/implantcast)

## Its most-cited devices
- K170444: PROCOTYL® PRIME Acetabular Cup System (2017), cited by 8
- K152298: EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base (2015), cited by 5
- K162026: EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions (2017), cited by 5
- K140735: Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts (2014), cited by 4
- K171181: PROCOTYL® PRIME E-CLASS™ XLPE Liner (2017), cited by 4
- K142550: EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments (2014), cited by 4

## Recent decisions
- K262473: NEXUS® Hip Stem (Oct 1, 2026)
- K253728: EVOLUTION® AM BIOFOAM® Tibial System (Aug 21, 2026)
- K250444: NEXUS® Hip Stem (May 15, 2025)
- K243574: Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique (Feb 18, 2025)
- K240046: Ethylene Oxide Sterilization Supplier Change for MPO Hips (Apr 18, 2024)
- K240452: Ceramic Femoral Head (Apr 12, 2024)
- K240043: EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse (Apr 1, 2024)
- K233507: EVOLUTION® Tibial Cones (Jan 18, 2024)

Source page: https://510kreport.com/company/microport-orthopedics