Cleared Traditional

K983144 - FLEXPOSURE RETRACTOR

K983144 is an FDA 510(k) clearance for FLEXPOSURE RETRACTOR, manufactured by Endius, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K983144 · Endius, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
169d
Days
Class 2
Risk

K983144 is an FDA 510(k) clearance for the FLEXPOSURE RETRACTOR. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Endius, Inc. (North Attleboro, US). The FDA issued a Cleared decision on February 24, 1999 after a review of 169 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 Endius, Inc. devices

FDA 510(k) Submission Details - K983144

510(k) Number K983144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date February 24, 1999
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
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 539
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K983144.
EBI VUECATH ENDOSCOPIC SYSTEN
K990459 · Electro-Biology, Inc. · Apr 1999
ABLATOR ELECTRODE
K983652 · Linvatec Corp. · Mar 1999
ARTHRO-SURGIMAT-2000 ECU
K990443 · W.O.M. World of Medicine GmbH · Feb 1999
KSEA C-MOUNT ARTHROSCOPES
K983142 · Karl Storz Endoscopy · Dec 1998
DCI ENDOSCOPE
K983384 · KARL STORZ Endoscopy-America, Inc. · Nov 1998
ARTHRO-SURGIMAT-1500
K983910 · W.O.M. World of Medicine GmbH · Nov 1998