Cleared Traditional

K831041 - SAGITTAL KNEE TESTER

K831041 is an FDA 510(k) clearance for SAGITTAL KNEE TESTER, manufactured by Orthopedic Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FTY cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K831041 · Orthopedic Systems, Inc. · General & Plastic Surgery device
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Jun 1983
Decision
85d
Days
Class 1
Risk

K831041 is an FDA 510(k) clearance for the SAGITTAL KNEE TESTER. Classified as Tape, Measuring, Rulers And Calipers (product code FTY), Class I - General Controls.

Submitted by Orthopedic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K831041

510(k) Number K831041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1983
Decision Date June 24, 1983
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

FTY Device Classification - Class 1, General Controls

Product Code FTY Tape, Measuring, Rulers And Calipers
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FTY Tape, Measuring, Rulers And Calipers

All 9
Devices cleared under the same product code (FTY) and FDA review panel - the closest regulatory comparables to K831041.
STRYKER PRESSURE MONITOR SYSTEM
K883485 · Stryker Corp. · Sep 1988
LN 100 BREAST MARKER
K872319 · Instrumentation Industries, Inc. · Aug 1987
ZIMMER OSSIMETER
K832899 · Zimmer, Inc. · Oct 1983
EXTENDED TUMOR CALIPER
K811278 · Mick Radio-Nuclear Instruments, Inc. · Jun 1981
PROXIMATE (TMD) TISSUE MEASURING DEVICE
K801374 · Ethicon, Inc. · Jun 1980
SURGICAL RULER
K790660 · Richard-Allan Medical Ind., Inc. · Apr 1979