Cleared Traditional

K790488 - INTERPLANTA SP TOTAL HIP PROSTHESIS

K790488 is an FDA 510(k) clearance for INTERPLANTA SP TOTAL HIP PROSTHESIS, manufactured by Waldemar Link GmbH & Co. KG. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K790488 · Waldemar Link GmbH & Co. KG · Orthopedic device
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Mar 1979
Decision
16d
Days
Class 2
Risk

K790488 is an FDA 510(k) clearance for the INTERPLANTA SP TOTAL HIP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Waldemar Link GmbH & Co. KG (Walker, US). The FDA issued a Cleared decision on March 28, 1979 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 - K790488

510(k) Number K790488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1979
Decision Date March 28, 1979
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K790488.
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K802872 · Howmedica Corp. · Dec 1980
DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
K800894 · Depuy, Inc. · May 1980
3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM
K800487 · 3M Company · Apr 1980
CUP, ACETABULAR, LONG POSTERIOR WALL
K780398 · Orthopedic Equipment Co., Inc. · Mar 1978
TOTAL HIP SYSTEM, HARRIS HD2
K780317 · Howmedica Corp. · Mar 1978
PROSTHESIS, DOUBLE CUP
K780052 · Depuy, Inc. · Jan 1978