Cleared Traditional

K072629 - DIGIMATCH ROBODOC SURGICAL SYSTEM (FDA 510(k) Clearance)

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

K072629 · Integrated Surgical Systems, Inc. · Orthopedic device
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Aug 2008
Decision
324d
Days
Class 2
Risk

K072629 is an FDA 510(k) clearance for the DIGIMATCH ROBODOC SURGICAL SYSTEM. Classified as Orthopedic Computer Controlled Surgical System (product code OJP), Class II - Special Controls.

Submitted by Integrated Surgical Systems, Inc. (Sacremento, US). The FDA issued a Cleared decision on August 6, 2008 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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. Elevated predicate reliance profile. 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 Integrated Surgical Systems, Inc. devices

Submission Details

510(k) Number K072629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2007
Decision Date August 06, 2008
Days to Decision 324 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
202d slower than avg
Panel avg: 122d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OJP Orthopedic Computer Controlled Surgical System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Pre-operative Planning And Intra-operative Execution Of Surgical Movements With Robotically Controlled End Effectors Under User Supervision. Alternative To Manual Planning And Broaching/reaming Techniques For Femoral Canal Preparation In Primary Total Hip Arthroplasty (tha).
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.