← Product Code [NKB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB) · K070995 # ARX-LINK CROSS CONNECTOR (K070995) _Life Spine · NKB · Jun 22, 2007 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K070995 ## Device Facts - **Applicant:** Life Spine - **Product Code:** [NKB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB.md) - **Decision Date:** Jun 22, 2007 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3070 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion. When used as a posterior spine thoracic/lumbar system, the ARX® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis. ## Device Story ARX-Link™ Cross Connector is a titanium alloy, multi-component spinal fixation system; designed as an add-on to the existing ARX® Spinal System (K061600). Components are non-sterile, single-use; attached to the vertebral body via screws in the non-cervical spine. Used by surgeons in clinical settings to build spinal implant constructs; provides stabilization and immobilization of spinal segments as an adjunct to fusion. Device acts as a load-sharing implant to maintain alignment during bone healing. Benefits include structural support for patients with degenerative disc disease, trauma, or spinal deformities. ## Clinical Evidence Bench testing only. Biomechanical testing was conducted in accordance with ASTM F1717 to demonstrate substantial equivalence. ## Technological Characteristics Titanium alloy (ASTM F136, Ti 6AL-4V-ELI). Multi-component, non-sterile, single-use spinal fixation system. Designed for posterior pedicle screw fixation. Mechanical load-sharing device. ## Regulatory Identification (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems. ## Special Controls *Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section. ## Predicate Devices - Life Spine ARX® Spinal Implant System ([K061600](/device/K061600.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The logo is in a bold, sans-serif font and is black. The registered trademark symbol is to the right of the word "Spine". K070995 #### 510(k) Summary # JUN 2 2 2007 ## 510(k) Summary - ARX-Link™ Cross Connector | Submitted By: | Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact: | Rebecca Brooks
Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 | | Date Prepared: | April 5, 2007 | | Trade Name: | ARX-Link™ Cross Connector | | Common Name: | Appliance, Fixation, Spinal Interlaminal | | Classification: | 888.3070 Pedicle screw spinal system | | Device Product Code: | MNH, 21 CFR 888.3070, Class II
MNI, 21 CFR 888.3070, Class II
NKB, 21 CFR 888.3070, Class III | | Predicate Device: | Life Spine ARX® Spinal Implant System K061600 | #### Device Description: The ARX-Link™ Cross Connector is a titanium alloy, multiple component system comprised of a variety of non-sterile single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The ARX-Link [M Cross Connector is available in various sizes. This device is an addition to the current system (K061600) and therefore is fully cross-functional within the current system. {1}------------------------------------------------ # Life S #### Intended Use of the Device: #### ARX® Spinal System Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion. When used as a posterior spine thoracic/lumbar system, the ARX® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis. #### Material: Manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI) implant grade titanium alloy. #### Performance Data: Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalence. #### Substantial Equivalence: The ARX-Link™ Cross Connector was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Life Spine, Inc. % Ms. Rebecca Brooks Project Coordinator 2401 W. Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169 JUN 2 2 2007 Re: K070995 Trade/Device Name: ARX-Link™ Cross Connector Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: May 21, 2007 Received: May 23, 2007 Dear Ms. Brooks: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of deveness, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Dan); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radition control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Ms. Rebecca Brooks This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Qorbare Buell Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Life Spine. The logo is in a sans-serif font and is black. There is a registered trademark symbol to the right of the word "Spine". ### Indications for Use 510(k) number (if known): _K07 0995 Device Name: ARX-Link™ Cross Connector ARX® Spinal System Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion. When used as a posterior spine thoracic/lumbar system, the ARX® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis, Prescription Use x (Part 21 CFR 801 Subpart D) And/Or Over-the-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Aubere buemp for nxm (Division Sign Off) (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K0701995 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K070995](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K070995) **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