Cleared Traditional

K122783 - PLASMAFIT ACETABULAR CUP AND VITELENE INSERT (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122783 · Aesculap Implant System, Inc. · Orthopedic device
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Oct 2013
Decision
414d
Days
Class 2
Risk

K122783 is an FDA 510(k) clearance for the PLASMAFIT ACETABULAR CUP AND VITELENE INSERT. Classified as Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented (product code OQG), Class II - Special Controls.

Submitted by Aesculap Implant System, Inc. (Center Valley, US). The FDA issued a Cleared decision on October 30, 2013 after a review of 414 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Aesculap Implant System, Inc. devices

Submission Details

510(k) Number K122783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2012
Decision Date October 30, 2013
Days to Decision 414 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
292d slower than avg
Panel avg: 122d · This submission: 414d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.