Cleared Traditional

K841241 - ANTERIOR CRUCIATE LIGAMENT GRASPER

K841241 is an FDA 510(k) clearance for ANTERIOR CRUCIATE LIGAMENT GRASPER, manufactured by Surgical Products Corp.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 320-day FDA review.

K841241 · Surgical Products Corp. · Orthopedic device
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Feb 1985
Decision
320d
Days
Class 2
Risk

K841241 is an FDA 510(k) clearance for the ANTERIOR CRUCIATE LIGAMENT GRASPER. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Surgical Products Corp. (Salt Lake City, US). The FDA issued a Cleared decision on February 6, 1985 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Surgical Products Corp. devices

FDA 510(k) Submission Details - K841241

510(k) Number K841241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1984
Decision Date February 06, 1985
Days to Decision 320 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 122d · This submission: 320d
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 560
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K841241.
CO2 FOR ARTHROSCOPY
K852592 · The Anspach Effort, Inc. · Aug 1985
AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE
K851374 · American Edwards Laboratories · Jun 1985
CODMAN ARTHROSCOPE
K851229 · Codman & Shurtleff, Inc. · May 1985
RICHARD ARTHROSCOPE
K843604 · Richards Medical Co., Inc. · Oct 1984
ACUFEX ARTHROSCOPE
K843208 · Acufex Microsurgical, Inc. · Sep 1984
AMERICAN EDWARDS LABS FLEXISCOPE
K841607 · American Edwards Laboratories · Aug 1984