Cleared Traditional

K140701 - NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E ...

K140701 is an FDA 510(k) clearance for NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E ..., manufactured by Novosource, Inc.. The device is a Class 2 Orthopedic device with product code OQG cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K140701 · Novosource, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jun 2014
Decision
99d
Days
Class 2
Risk

K140701 is an FDA 510(k) clearance for the NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG. Classified as Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented (product code OQG), Class II - Special Controls.

Submitted by Novosource, Inc. (Indianpolis, US). The FDA issued a Cleared decision on June 27, 2014 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Novosource, Inc. devices

FDA 510(k) Submission Details - K140701

510(k) Number K140701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2014
Decision Date June 27, 2014
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OQG Device Classification - Class 2, Special Controls

Product Code OQG Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
Definition 1. Non-inflammatory Degenerative Joint Disease Including Osteoarthritis And Avascular Necrosis. 2. Rheumatoid Arthritis. 3. Correction Of Functional Deformity. 4. Treatment Of Non-union, Femoral Neck Fracture, And Trochanteric Fractures Of The Proximal Femur With Head Involvement, Unmanageable By Other Techniques. 5. Revision Procedures Where Other Treatment Or Devices Have Failed. Cemented And Uncemented Use.
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 - OQG Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented

All 13
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