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FDA 510(k)

SIGMA High Performance (HP) Partial Knee System

K-Number: K193549 · 2020-04-16

ApplicantDepuy Ireland UC
Decision Date2020-04-16
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SIGMA High Performance (HP) Partial Knee System is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2020-04-16 under approval number K193549. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA High Performance (HP) Partial Knee System?

SIGMA High Performance (HP) Partial Knee System is a medical device that received FDA 510(k) clearance on 2020-04-16. It is manufactured by Depuy Ireland UC. The 510(k) number is K193549.

When was SIGMA High Performance (HP) Partial Knee System approved by the FDA?

SIGMA High Performance (HP) Partial Knee System received FDA 510(k) clearance on 2020-04-16, under approval number K193549.

What company makes SIGMA High Performance (HP) Partial Knee System?

SIGMA High Performance (HP) Partial Knee System is manufactured by Depuy Ireland UC.

What is the FDA product code for SIGMA High Performance (HP) Partial Knee System?

The FDA product code for SIGMA High Performance (HP) Partial Knee System is HRY.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41443207 Artificial Intelligence in UK Hospital Medicine: From Innovation to Implementation. British journal of hospital medicine (London, England : 2005) (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Depuy Ireland UC

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Related Devices (Code: HRY)

K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc. K190633NanoOrtho NanoKnee® SystemNanoortho, LLC

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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