Cleared Traditional

K934162 - PROFORM HA HIP SYSTEM

K934162 is an FDA 510(k) clearance for PROFORM HA HIP SYSTEM, manufactured by Stelkast Company. The device is a Class 2 Orthopedic device with product code JDO cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K934162 · Stelkast Company · Orthopedic device
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Mar 1994
Decision
194d
Days
Class 2
Risk

K934162 is an FDA 510(k) clearance for the PROFORM HA HIP SYSTEM. Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on March 9, 1994 after a review of 194 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Stelkast Company devices

FDA 510(k) Submission Details - K934162

510(k) Number K934162 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 27, 1993
Decision Date March 09, 1994
Days to Decision 194 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
72d slower than avg
Panel avg: 122d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDO Device Classification - Class 2, Special Controls

Product Code JDO Device, Fixation, Proximal Femoral, Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDO Device, Fixation, Proximal Femoral, Implant

All 22
Devices cleared under the same product code (JDO) and FDA review panel - the closest regulatory comparables to K934162.
TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS)
K953607 · Synthes (Usa) · Mar 1996
SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX]
K951904 · Synthes (Usa) · Jul 1995
PROFORM HIP SYSTEM
K934161 · Stelkast Company · Mar 1994
SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
K923613 · Synthes (Usa) · Jun 1993
COMPRESSION SYSTEM
K831076 · Kirschner Medical Corp. · Apr 1983
PROXIMAL FERMORAL HIP REPLACEMENT
K810258 · Biomet, Inc. · Mar 1981