Cleared Traditional

K072629 - DIGIMATCH ROBODOC SURGICAL SYSTEM

K072629 is an FDA 510(k) clearance for DIGIMATCH ROBODOC SURGICAL SYSTEM, manufactured by Integrated Surgical Systems, Inc.. The device is a Class 2 Orthopedic device with product code OJP cleared through the Traditional 510(k) pathway after a 324-day FDA review.

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

FDA 510(k) Submission Details - K072629

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.

OJP Device Classification - Class 2, Special Controls

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.