Cleared Traditional

ANTERIOR CRUCIATE LIGAMENT GRASPER (K841241) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 178
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K841241.
THE KARL STORZ MODEL 28805 ARTHRO PUMP
K871621 · KARL STORZ Endoscopy-America, Inc. · Jun 1987
SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM
K870915 · C.R. Bard, Inc. · Apr 1987
CODMAN ARTHROSCOPE
K851229 · Codman & Shurtleff, Inc. · May 1985
ZIMMER ARTHROSCOPY SYSTEM
K811596 · Zimmer, Inc. · Jun 1981
SURGICAL INSTRUMENTS FOR USE W/ZIMMER
K811675 · Zimmer, Inc. · Jun 1981
NEEDLE, SPRAY
K770710 · Richard Wolf Medical Instruments Corp. · Apr 1977