Cleared Traditional

K951267 - STRYKER UNIVERSAL ACL INSTRUMENTATION S...

K951267 is an FDA 510(k) clearance for STRYKER UNIVERSAL ACL INSTRUMENTATION S..., 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 164-day FDA review.

K951267 · Stryker Endoscopy · Orthopedic device
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Sep 1995
Decision
164d
Days
Class 2
Risk

K951267 is an FDA 510(k) clearance for the STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Stryker Endoscopy (Santa Clara, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 164 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 - K951267

510(k) Number K951267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date September 01, 1995
Days to Decision 164 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
42d slower than avg
Panel avg: 122d · This submission: 164d
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 415
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K951267.
DISPOSABLE TOOTHED GRASPING FORCEP
K952639 · Neuro Navigational Corp. · Sep 1995
MICRO-ARTHROSCOPE
K930084 · Medical Devices, Inc. · Sep 1995
STRYKER PRESSURE SENSING CANNULA
K944593 · Stryker Endoscopy · Sep 1995
UNIMAT PUMP
K953075 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
CO2 ARTHROFLATOR
K953550 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES
K950093 · Smith & Nephew Richards, Inc. · Aug 1995