Cleared Traditional

K781735 - ENDOPROSTHESIS SYSTEM

K781735 is an FDA 510(k) clearance for ENDOPROSTHESIS SYSTEM, manufactured by Waldemar Link GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K781735 · Waldemar Link GmbH & Co. KG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
12d
Days
Class 2
Risk

K781735 is an FDA 510(k) clearance for the ENDOPROSTHESIS SYSTEM, VARIO-HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Waldemar Link GmbH & Co. KG (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Waldemar Link GmbH & Co. KG devices

FDA 510(k) Submission Details - K781735

510(k) Number K781735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1978
Decision Date October 24, 1978
Days to Decision 12 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
110d faster than avg
Panel avg: 122d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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.