Cleared Traditional

K941691 - REVO ROTATOR CUFF REPAIR SYSTEM

K941691 is an FDA 510(k) clearance for REVO ROTATOR CUFF REPAIR SYSTEM, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K941691 · Linvatec Corp. · Orthopedic device
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Sep 1994
Decision
153d
Days
Class 2
Risk

K941691 is an FDA 510(k) clearance for the REVO ROTATOR CUFF REPAIR SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on September 6, 1994 after a review of 153 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Linvatec Corp. devices

FDA 510(k) Submission Details - K941691

510(k) Number K941691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1994
Decision Date September 06, 1994
Days to Decision 153 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 521
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K941691.
ACUFEX(R) ENDO-FEMORAL AIMER
K942846 · Acufex Microsurgical, Inc. · Sep 1994
ARTHRO-FLO IRRIGATION SYSTEM MODIFICATION
K935617 · Davol Inc., Sub. C. R. Bard, Inc. · Sep 1994
INNOVASIVE ARTHROSCOPIC ROC SUTURE BONE FASTENER
K941273 · Innovasive Devices, Inc. · Sep 1994
CARPAL TUNNEL SYSTEM
K940234 · Richard Wolf Medical Instruments Corp. · Aug 1994
SMITH AND NEPHEW SPINE DEFLECTING FORCEPS
K940222 · Smith & Nephew, Inc. · Jun 1994
ACUFEX DISPOSABLE MENISCAL CANNULA
K932090 · Acufex Microsurgical, Inc. · Jun 1994