← Product Code [OLO](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO) · K103400 # FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP (K103400) _Stryker Corporation · OLO · Mar 7, 2011 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-e%E2%80%94neurological-surgical-devices/OLO/K103400 ## Device Facts - **Applicant:** Stryker Corporation - **Product Code:** [OLO](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OLO.md) - **Decision Date:** Mar 7, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use FluoroMap is a computer controlled stereotaxic image guided surgery system. It provides static localization information derived from image processing of intra-operatively acquired Xray images, by superposition of virtual implants and instruments onto those X-ray images. ## Device Story FluoroMap is a computer-assisted surgical planning system for proximal femur fracture surgery. It utilizes intra-operative 2D X-ray images as input. The system includes the FluoroMap software, a FluoroDisc (attached to a C-arm), and a Closed Tube Clip (attached to the Gamma3 Nail implant). The software recognizes metal marker spheres on the FluoroDisc and Closed Tube Clip to register X-ray images and localize the implant system. It overlays virtual implants and instruments onto the X-ray images, providing visual and numerical guidance to the surgeon. Used in the surgical suite by surgeons and clinical staff, the system assists in selecting and precisely positioning implants. This guidance aims to improve surgical accuracy and implant placement, potentially benefiting patients by optimizing fracture fixation. ## Clinical Evidence No clinical tests were conducted. Evidence is based on bench testing, including cadaveric studies, saw bone tests, and computer simulations. The system demonstrated a 2 mm accuracy (maximal deviation between displayed and actual implant position) with statistical significance. Usability was validated against IEC 62366:2007 standards in simulated use scenarios. ## Technological Characteristics Computer-assisted stereotaxic image-guided surgery system. Components: FluoroMap software, FluoroDisc (radiolucent plate with metal marker spheres), and Closed Tube Clip (radiolucent body with metal marker spheres). Connectivity: Integrates with standard C-arm imaging. Sterilization: Closed Tube Clip is sterile, single-use. Compliance: ISO 14971 (risk management), IEC 62366 (usability), and various AAMI/ANSI/ISO standards for biocompatibility and sterility (e.g., 10993 series, 11137 series). ## Regulatory Identification A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. ## Predicate Devices - VectorVision trauma ([K062358](/device/K062358.md)) - TenZing System ([K102130](/device/K102130.md)) - Gamma3 Lag Screw ([K020677](/device/K020677.md)) - Gamma3 Trochanteric Nail ([K032244](/device/K032244.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K103400 # MAR - 7 2011 # 510(k) SUMMARY A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 . | Submitter Information | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Name | Stryker Leibinger GmbH & Co. KG - Navigation | | | Address | Boetzinger Strasse 41, D-79111 Freiburg, Germany | | | Phone number | +49-761-4512-117 | | | Fax number | +49-761-4512-49117 | | | Establishment Registration Number | 3007582679 | | | Name of contact person | Lilian Eckert | | | Date prepared | 17 November 2010 | | | Name of device | | | | Trade or proprietary name | FluoroMap Computer Assisted Surgery System | | | Common or usual name | FluoroMap System | | | Classification name | Orthopedic stereotaxic instrument and Picture archiving and communications system | | | Classification panel | Orthopedic and Radiology | | | Regulation | §882.4560 | | | Product Code(s) | OLO and LLZ | | | Legally marketed device(s) to which equivalence is claimed | VectorVision trauma from BrainLAB AG, K062358
TenZing System from Mazor Surgical Technologies Ltd., K102130
Gamma3 Lag Screw from Stryker Trauma GmbH, K020677
Gamma3 Trochanteric Nail from Stryker Trauma GmbH, K032244 | | | Reason for 510(k) submission | Traditional 510(k) Notification | | | Device description | The FluoroMap System is designed as a computer assisted surgical planning device to assist the surgeon in proximal femur fracture surgery.
The FluoroMap System provides static localization information derived through image processing of intra-operatively acquired X-ray images, by superposition of virtual implants and instruments onto those X-ray images.
The FluoroMap System consists of the FluoroMap Software, the FluoroDisc and the Closed Tube Clip. The Closed Tube Clip is a device which contains a radiolucent body with integrated metal marker spheres. The Closed Tube Clip is attached to the implant system of the Gamma3 Nail. The FluoroDisc | | | is a device which contains a radiolucent plate with integrated metal marker
spheres. It is attached to a standard C-arm, an intra-operative mobile 2D X-
ray imaging device. The FluoroMap Software is a surgery planning system
which recognizes the metal marker spheres of the FluoroDisc and the Close
Tube Clip and performs a registration of the X-ray images to localize the
position of the implant system, e.g. the Gamma3 Nail system. The
FluoroMap Software overlays virtual implants and instruments onto the X-
ray images and provides visual and numerical information to assist the
surgeon in selecting the appropriate implant and to position it precisely. | | | | Intended use of the
device | FluoroMap is a computer controlled stereotaxic image guided surgery
system. It provides static localization information derived from image
processing of intra-operatively acquired X-ray images, by superposition of
virtual implants and instruments onto those X-ray images. | | | Indications for use | FluoroMap assists the surgeon to determine the needed size and position
of orthopedic implants during proximal femur fracture surgery using the
Stryker Gamma3 Nail system.
The system should be operated only by trained personnel such as
surgeons and clinic staff. | | | Summary of the technological characteristics of the device compared to the predicate device
1 | | | | Characteristic | Subject Device
FluoroMap | Predicate device 1
VectorVision trauma, BrainLAB
AG, K062358 | | Intended Use /
Indication for Use
Statement | Intended Use:
FluoroMap is a computer controlled
stereotaxic image guided surgery
system. It provides static localization
information derived from image
processing of intra-operatively acquired
X-ray images, by superposition of virtual
implants and instruments onto those X-
ray images.
Indications:
FluoroMap assists the surgeon to
determine the needed size and position
of orthopedic implants during proximal
femur fracture surgery using the Stryker
Gamma3 Nail system.
The system should be operated only by
trained personnel such as surgeons and
clinic staff. | BrainLAB VectorVision trauma is
intended to be a pre- and intraoperative
image guided localization system to
enable minimally invasive surgery. It
links a freehand probe, tracked by a
passive marker sensor system to virtual
computer image space on a patient's
pre- or intraoperative image data being
processed by a VectorVision
workstation. The system is indicated for
any medical condition in which the use
of stereotactic surgery may be
appropriate and where a reference to a
rigid anatomical structure, such as the
skull, a bone structure like tubular
bones, pelvic, calcaneus and talus, or
vertebra, can be identified relative to a
CT, fluoroscopic, X-ray or MR based
model of the anatomy. | | Intended Patient
Population | Patients undergoing orthopedic surgery | Patients undergoing orthopedic surgery | | Surgical Approach | Orthopedic surgery, specifically at the
proximal femur | Orthopedic surgery, specifically surgery
at tubular bones, pelvic, calcaneus and
talus, or vertebra | | Operational
Environment | Surgical suite | Surgical suite | | Primary Device
Function | Assistance in planning and positioning of
orthopedic implants using intra-operative
X-ray images | Assistance in planning and positioning
of orthopedic implants using intra-
operative X-ray images | | Main System
Components | Software Reference device for C-arm Reference device for instrumentation | Software Reference device for C-arm Reference device for instrumentation Reference system for patient | | User Interface | Computer and monitor | Computer and monitor | | Bench Testing | Accuracy testing of implant positioning in
simulated use scenarios using cadavers,
saw bones and computer simulation;
system accuracy of 2 mm | Unknown, expected to be similar
accuracy tests with similar results | | Conformance to
Recognized
Consensus
Standards | Compliance with standards in regard to
risk management, usability, software,
sterilization, biocompatibility, packaging,
development process and quality
system, see section 1.11 | Unknown | | Body Contact and
Use | Reference device for instrumentation
(Closed Tube Clip) has patient contact | Reference device for instruments and
reference device for patient have body
contact | | Sterile, Single-use | Reference device for instrumentation
(Closed Tube Clip) is delivered sterile
and as a single use product | Parts of the reference device (infra-red
reflectors) are delivered sterile and are
single use products | | Summary of the technological characteristics of the device compared to the predicate device
2 | | | | Characteristic… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-e%E2%80%94neurological-surgical-devices/OLO/K103400](https://fda.innolitics.com/submissions/RA/subpart-e%E2%80%94neurological-surgical-devices/OLO/K103400) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com