510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202705Substantially Equivalent

Prime and DYNASTY® Additive Manufacturing Shells

Microport Orthopedics Inc., Arlington TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202705 is the FDA 510(k) clearance record for Prime and DYNASTY® Additive Manufacturing Shells, a class II device, cleared for Microport Orthopedics, Inc. on under FDA product code OQG (Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented). FDA's definition for product code OQG reads: "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...". FDA records list 38 510(k) clearances for Microport Orthopedics, Inc., from to . As of , FDA records show no recalls naming K202705.

Clearance record

Decision date
Received
(338 days to decision)
Product code
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Regulation
21 CFR 888.3358
Device class
Class II
Review panel
Orthopedic
Applicant
Microport Orthopedics, Inc. 5677 Airline Rd., Arlington TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQG

Trailing 12 months

FDA records hold no clearances under product code OQG in the trailing twelve months.

FDA records show no clearances under product code OQG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260