Cleared Traditional

Prime and DYNASTY? Additive Manufacturing Shells

K202705 · Microport Orthopedics, Inc. · Orthopedic

Aug 2021

Decision

338d

Days

Class 2

Risk

About This 510(k) Submission

K202705 is an FDA 510(k) clearance for the Prime and DYNASTY? Additive Manufacturing Shells, a Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented (Class II — Special Controls, product code OQG), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on August 20, 2021, 338 days after receiving the submission on September 16, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K202705 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2020
Decision Date	August 20, 2021
Days to Decision	338 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OQG — Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358
Definition	1. Non-inflammatory 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 By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.