510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K072629Substantially Equivalent

Digimatch Robodoc Surgical System

Integrated Surgical Systems, Inc., Sacremento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K072629 is the FDA 510(k) clearance record for DIGIMATCH ROBODOC SURGICAL SYSTEM, a class II device, cleared for Integrated Surgical Systems, Inc. on under FDA product code OJP (Orthopedic Computer Controlled Surgical System). FDA's definition for product code OJP reads: "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...". FDA records list 4 510(k) clearances for Integrated Surgical Systems, Inc., from to . As of , FDA records show no recalls naming K072629.

Clearance record

Decision date
Received
(324 days to decision)
Product code
OJP Orthopedic Computer Controlled Surgical System
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Integrated Surgical Systems, Inc. 1433 N. Market Blvd., #1, Sacremento CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OJP

Trailing 12 months

FDA records hold no clearances under product code OJP in the trailing twelve months.

FDA records show no clearances under product code OJP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OJP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260