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ARVIS® Shoulder

Insight Medical Systems, Inc.

Country / Region:United States (US)Submission type:Traditional

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

United States (US)

Product code

OLO
21 CFR 882.4560

Predicate devices

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K240062
Device name
ARVIS® Shoulder
Country / Region
United States(US)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2024-01-09
Decision date
2024-04-29
Submission type
Traditional

Indications for Use

ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging. ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate implant system.

Intended Use

ARVIS® Shoulder is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements and locating anatomical structures of the shoulder joint based on the patient's preoperative imaging. ARVIS® Shoulder is indicated for total shoulder arthroplasty using the Enovis AltiVate implant system.

Device Description

ARVIS® Shoulder is a computer-controlled surgical navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The subject device is the equivalent shoulder system of the predicate ARVIS® Surgical Navigation System used for indicated knee and hip arthroplasties. ARVIS® Shoulder combines software, electronic hardware and surgical instruments to intraoperatively track tools and locate anatomical structures based on the patient's preoperative imaging.

Summary parsed at:2026-06-19 05:30:03 UTC

Predicate devices

3

K240062 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K240062 as a predicate