Cleared Traditional

INTEGRATED ENDOSCOPY SYSTEM 1000 (K920800) - FDA 510(k) Clearance

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

K920800 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
130d
Days
Class 2
Risk

K920800 is an FDA 510(k) clearance for the INTEGRATED ENDOSCOPY SYSTEM 1000. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 30, 1992 after a review of 130 days - within the typical 510(k) review window.

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 Biomet, Inc. devices

Submission Details

510(k) Number K920800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1992
Decision Date June 30, 1992
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
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 177
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K920800.
ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES
K922890 · Arthrex, Inc. · Feb 1993
ARTHREX ATRAUMATIC MINI-GRASPER
K925455 · Arthrex, Inc. · Feb 1993
ARTHREX ARTHROSCOPY ICE BLADE
K921823 · Arthrex, Inc. · Oct 1992
MODEL AR-6300 INFUSION PUMP
K915721 · Arthrex, Inc. · Mar 1992
3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA
K912099 · 3M Company · Dec 1991
MOTOR DRIVEN EXTIRPATION INSTRUMENTS
K904859 · Aesculap, Inc. · Mar 1991