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FDA 510(k)

SPAR-K Instruments (for use with Gemini SL Total Knee System)

K-Number: K191755 · 2019-07-18

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2019-07-18
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPAR-K Instruments (for use with Gemini SL Total Knee System) is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2019-07-18 under approval number K191755. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPAR-K Instruments (for use with Gemini SL Total Knee System)?

SPAR-K Instruments (for use with Gemini SL Total Knee System) is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K191755.

When was SPAR-K Instruments (for use with Gemini SL Total Knee System) approved by the FDA?

SPAR-K Instruments (for use with Gemini SL Total Knee System) received FDA 510(k) clearance on 2019-07-18, under approval number K191755.

What company makes SPAR-K Instruments (for use with Gemini SL Total Knee System)?

SPAR-K Instruments (for use with Gemini SL Total Knee System) is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for SPAR-K Instruments (for use with Gemini SL Total Knee System)?

The FDA product code for SPAR-K Instruments (for use with Gemini SL Total Knee System) is JWH.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018) PMID: 28280294 Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. Journal of health care finance (2016)

Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K182321MobileLink Acetabular Cup System

View all 29 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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