Cleared Traditional

ENDO-BEND(TM) SHAVER (K950054) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950054 · Paladin Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
174d
Days
Class 2
Risk

K950054 is an FDA 510(k) clearance for the ENDO-BEND(TM) SHAVER. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on June 29, 1995 after a review of 174 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 Paladin Medical, Inc. devices

Submission Details

510(k) Number K950054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1995
Decision Date June 29, 1995
Days to Decision 174 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 122d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 163
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K950054.
TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY
K955272 · KARL STORZ Endoscopy-America, Inc. · Dec 1995
UNIMAT PUMP
K953075 · KARL STORZ Endoscopy-America, Inc. · Sep 1995
CO2 ARTHROFLATOR
K953550 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES
K945787 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
KARL STORZ KNIVES, CURETTS, HOOKS, PROBES
K945891 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES
K952192 · KARL STORZ Endoscopy-America, Inc. · Jun 1995