Cleared Traditional

K935221 - STRYKER ARTHROSCOPIC MANUAL SURGICAL IN...

K935221 is an FDA 510(k) clearance for STRYKER ARTHROSCOPIC MANUAL SURGICAL IN..., manufactured by Stryker Endoscopy. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K935221 · Stryker Endoscopy · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
178d
Days
Class 2
Risk

K935221 is an FDA 510(k) clearance for the STRYKER ARTHROSCOPIC MANUAL SURGICAL INSTRUMENTS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Stryker Endoscopy (San Jose, US). The FDA issued a Cleared decision on April 28, 1994 after a review of 178 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 Stryker Endoscopy devices

FDA 510(k) Submission Details - K935221

510(k) Number K935221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date April 28, 1994
Days to Decision 178 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 122d · This submission: 178d
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 413
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K935221.
ACUFEX(R) ARTHROPLASTY INSTRUMENTS
K940985 · Acufex Microsurgical, Inc. · May 1994
ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS
K941364 · Acufex Microsurgical, Inc. · May 1994
ACUFEX ARTHROSCOPIC SHOULDER GUIDE SYSTEM
K940481 · Acufex Microsurgical, Inc. · May 1994
ACUFEX ARTHROSCOPIC SUTURE CUTTER
K940506 · Acufex Microsurgical, Inc. · Apr 1994
ACUFEX SURETAC IXC SYSTEMS
K940623 · Acufex Microsurgical, Inc. · Apr 1994
ARTHROSCOPE, DISPOSABLE
K933576 · United States Surgical, A Division of Tyco Healthc · Apr 1994