Cleared Traditional

K920037 - OSTEO COMPRESSION HIP SCREW

K920037 is an FDA 510(k) clearance for OSTEO COMPRESSION HIP SCREW, manufactured by Osteo AG. The device is a Class 2 Ophthalmic device with product code HRC cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K920037 · Osteo AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
65d
Days
Class 2
Risk

K920037 is an FDA 510(k) clearance for the OSTEO COMPRESSION HIP SCREW. Classified as Sterilizer, Soft-lens, Thermal, Battery-powered (product code HRC), Class II - Special Controls.

Submitted by Osteo AG (Greenwood, US). The FDA issued a Cleared decision on March 11, 1992 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic 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 Osteo AG devices

FDA 510(k) Submission Details - K920037

510(k) Number K920037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1992
Decision Date March 11, 1992
Days to Decision 65 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 110d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRC Device Classification - Class 2, Special Controls

Product Code HRC Sterilizer, Soft-lens, Thermal, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 Ophthalmic devices follow this clearance model.