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Cirq Arm System (2.0);Alignment System Spine

Brainlab AG

Country / Region:Germany (DE)Submission type:Special

Product code OLO· 21 CFR 882.4560

Summary PDF

Company

Germany (DE)

Product code

OLO
21 CFR 882.4560

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K222966
Device name
Cirq Arm System (2.0);Alignment System Spine
Country / Region
Germany(DE)
Product code
OLO
Device class
Class 2
Regulation number
21 CFR 882.4560
Date received
2022-09-27
Decision date
2022-10-27
Submission type
Special
Technology type
Software Navigation(AI inferred)
Clinical applications
Spine SurgeryNavigation System
Primary application
Spine Surgery
Classification source
AI classified

Indications for Use

As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.

Intended Use

As an accessory to the Spine & Trauma Navigation, the Alignment System Spine is intended to support the surgeon to achieve a pre-defined screw with surgical instruments during the surgical procedure. It is used for spinal screw placement procedures.

Device Description

The Cirq Arm System serves as a holding and positioning system to support the surgeon in reaching a pre-defined screw trajectory with surgical instruments. It consists of a passive, semi-rigid mechatronic arm system with structural components, several modules, instrument holding and clamping mechanisms and software to guide the user. The Cirq Arm System 2.0 is a passive mechatronic device for holding and positioning surgical instruments; it is evolved from its predecessor, the Surgical Base System 1.4 (K202320). The Cirq Arm System 2.0 is attached to the side rail of an operating table and is intended to be used in a hospital environment, specifically in rooms which are appropriate for surgical interventions (e.g. operating rooms). The base provides external power and communication with the IGS platforms and Alignment Software Spine (if applicable, ie. if used within the active configuration). The Cirq Arm System 2.0 can be manually positioned by releasing the brakes in the joints, using the integrated buttons. The brakes in the joints open when powered (a voltage is supplied), and close without current. Therefore, the brakes close in case of a power failure. The brake state is visualized to the user by LED rings showing different colors for the two different brake states (open/closed) separately for each joint. The electronics and firmware are designed to be ready to operate meaning that the arm can be booted and used quickly after connecting it to the power supply. The sterility of the device during the surgical intervention is ensured with a sterile drape, which is compatible to the Cirq Arm System 2.0 and the attached application module. The specific workflow and operating principles differ based on the attached module.

Summary parsed at:2026-06-24 04:37:24 UTC

Predicate devices

2
  • Not ingested

  • Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System

    Brainlab AG

K222966 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K222966 as a predicate