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FDA 510(k)

Prime and DYNASTY® Additive Manufacturing Shells

K-Number: K202705 · 2021-08-20

ApplicantMicroport Orthopedics, Inc.
Decision Date2021-08-20
Product CodeOQG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prime and DYNASTY® Additive Manufacturing Shells is a medical device manufactured by Microport Orthopedics, Inc.. It received FDA 510(k) clearance on 2021-08-20 under approval number K202705. The device is classified under product code OQG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prime and DYNASTY® Additive Manufacturing Shells?

Prime and DYNASTY® Additive Manufacturing Shells is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Microport Orthopedics, Inc.. The 510(k) number is K202705.

When was Prime and DYNASTY® Additive Manufacturing Shells approved by the FDA?

Prime and DYNASTY® Additive Manufacturing Shells received FDA 510(k) clearance on 2021-08-20, under approval number K202705.

What company makes Prime and DYNASTY® Additive Manufacturing Shells?

Prime and DYNASTY® Additive Manufacturing Shells is manufactured by Microport Orthopedics, Inc..

What is the FDA product code for Prime and DYNASTY® Additive Manufacturing Shells?

The FDA product code for Prime and DYNASTY® Additive Manufacturing Shells is OQG.

Related Clinical Trials

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Related PubMed Literature

PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026) PMID: 41034609 Influence of geometry, reinforcement, and sterilisation on the dimensional accuracy of additively manufactured carbon fibre-reinforced nylon composites. Scientific reports (2025) PMID: 40528079 The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey. Therapeutic innovation & regulatory science (2025)

Other Devices by Microport Orthopedics, Inc.

K152631MPO Total Knee Systems MR Labeling K171181PROCOTYL® PRIME E-CLASS™ XLPE Liner K171389EVOLUTION Revision CCK System K170444PROCOTYL® PRIME Acetabular Cup System K170288BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell K162026EVOLUTION 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

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Related Devices (Code: OQG)

K172651FMP Extended LinersEncore Medical L.P. K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile Acetabular Insert with E-Link® PolyTotal Joint Orthopedics, Inc. K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc. K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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