Cleared Traditional

K925577 - DANEK TISSUE RESECTING SYSTEM

K925577 is an FDA 510(k) clearance for DANEK TISSUE RESECTING SYSTEM, manufactured by Sofamor Danek Mfg., Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K925577 · Sofamor Danek Mfg., Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
156d
Days
Class 2
Risk

K925577 is an FDA 510(k) clearance for the DANEK TISSUE RESECTING SYSTEM. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Sofamor Danek Mfg., Inc. (Memphis, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 156 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 Sofamor Danek Mfg., Inc. devices

FDA 510(k) Submission Details - K925577

510(k) Number K925577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date April 08, 1993
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
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 K925577.
RESTORE TUNNEL PLUG
K923069 · Depuy, Inc. · Jun 1993
ACUFEX T-BAR
K925573 · Acufex Microsurgical, Inc. · May 1993
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
K924144 · Davol, Inc. · Apr 1993
DANEKSCOPE AND ACCESSORIES
K911729 · Danek Medical, Inc. · Apr 1993
SYMBIOSIS DISPOSABLE ARTHROSCOPIC SURGICAL INST.
K924017 · Symbiosis Corp. · Mar 1993
ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES
K925996 · Arthrex, Inc. · Mar 1993