Manufacturer
Brainlab AGCirq Arm System (2.0);Alignment System Spine
Country / Region:Germany (DE)Submission type:Special
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K222966
- Device name
- Cirq Arm System (2.0);Alignment System Spine
- Company
- Brainlab AG
- 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—
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Not ingested
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System
K222966 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K222966 as a predicate
