Cleared Traditional

K950054 - ENDO-BEND(TM) SHAVER

K950054 is an FDA 510(k) clearance for ENDO-BEND(TM) SHAVER, manufactured by Paladin Medical, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K950054 · Paladin Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K950054

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
Combination Product No
PCCP Authorized No
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.

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 647
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K950054.
ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
K951624 · Argus Medical Co., Inc. · Jul 1995
REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT
K951843 · Future Medical Systems, Inc. · Jul 1995
CITATION MULTIPLE USE DELTA SCOPE
K951941 · Citation Medical Corp. · Jul 1995
CITATION DELTA SCOPE
K945390 · Citation Medical Corp. · Jun 1995
CITATION POWER TOOL
K946290 · Citation Medical Corp. · Jun 1995
POC ARTHROSCOPE AND ACCESSORIES
K945684 · Precision Optics Corp. · Jun 1995
K950054 · ENDO-BEND(TM) SHAVER
Download PDF FDA Summary Paladin Medical, Inc.