Cleared Traditional

K860207 - S-ROM 135 POROUS COATED FEMORAL STEM COLLAR

K860207 · Joint Medical Products Corp. · Orthopedic device
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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

FDA 510(k) Submission Details - K860207

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -