Cleared Traditional

K896678 - SILICONE PLUG

K896678 is an FDA 510(k) clearance for SILICONE PLUG, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K896678 · Orthopedic Systems, Inc. · Orthopedic device
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Jan 1990
Decision
64d
Days
Class 2
Risk

K896678 is an FDA 510(k) clearance for the SILICONE PLUG. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on January 30, 1990 after a review of 64 days - a notably fast clearance 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: 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 - K896678

510(k) Number K896678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date January 30, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
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 393
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K896678.
ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)
K902168 · Micro-Aire Surgical Instruments, Inc. · Jun 1990
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)
K901617 · Smith & Nephew, Inc. · May 1990
MEDICAM ARTHROSCOPE SYSTEMS
K900812 · Kirschner Medical Corp. · May 1990
ARTHROSCOPIC TUBING SHEATH
K896584 · Origin Medsystems, Inc. · Dec 1989
DAVOL ARTHROSCOPY CANNULA
K894990 · Davol, Inc. · Nov 1989
INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
K892376 · Concept, Inc. · Aug 1989