OJPClass II

Orthopedic Computer Controlled Surgical System

21 CFR 882.4560 / Neurology

OJP is the FDA product code for Orthopedic Computer Controlled Surgical System, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code 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 primary total hip arthroplasty (THA)". As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 2015-10-22, and no recalls.

Classification record

Product code: OJP
Device name: Orthopedic Computer Controlled Surgical System
FDA 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).
Regulation: 21 CFR 882.4560
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 0

Clearances, product code OJP

By decision year

4 clearances under product code OJP with a decision year between 2008 and 2015, 2014 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code OJP by decision year
Year	Clearances
2008	1
2014	2
2015	1

Applicants with the most clearances

Product code OJP

Applicants holding the most 510(k) clearances under product code OJP
Applicant	Clearances
Curexo Technology Corporation	2
Integrated Surgical Systems, Inc.	1
Think Surgical Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OJP

Recent recalls

Product code OJP

FDA records show no recalls under product code OJP.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)