Cleared Traditional

K860207 - S-ROM 135 POROUS COATED FEMORAL STEM COLLAR (FDA 510(k) Clearance)

K860207 · Joint Medical Products Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
196d
Days
-
Risk

K860207 is an FDA 510(k) clearance for the S-ROM 135 POROUS COATED FEMORAL STEM COLLAR.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on August 6, 1986 after a review of 196 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. 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 Joint Medical Products Corp. devices

Submission Details

510(k) Number K860207 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 22, 1986
Decision Date August 06, 1986
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -