Who is the manufacturer of ANY PLUS SPINAL FIXATION SYSTEM?

GS Medical Co., Ltd. filed the 510(k) submission for ANY PLUS SPINAL FIXATION SYSTEM (K091717).

What is the FDA product code for ANY PLUS SPINAL FIXATION SYSTEM?

NKB. It is classified under 21 CFR 888.3070 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for ANY PLUS SPINAL FIXATION SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ANY PLUS SPINAL FIXATION SYSTEM?

GSS Pedicle Screw System (K053573); Synthes Pangea System (K052123); INCOMPASS SPINAL FIXATION SYSTEM (K021564).

Who can help prepare an FDA 510(k) submission like ANY PLUS SPINAL FIXATION SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ANY PLUS SPINAL FIXATION SYSTEM

K091717 · GS Medical Co., Ltd. · NKB · Jan 25, 2010 · Orthopedic

Device Facts

Record ID	K091717
Device Name	ANY PLUS SPINAL FIXATION SYSTEM
Applicant	GS Medical Co., Ltd.
Product Code	NKB · Orthopedic
Decision Date	Jan 25, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3070
Device Class	Class 2
Attributes	Therapeutic

Intended Use

AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Device Story

AnyPlus Spinal Fixation System; rigid spinal construct system comprising hooks, screws, rods, and connectors. Used for immobilization and stabilization of non-cervical spine as adjunct to fusion. Operated by surgeons in clinical/OR settings. Components manufactured from Ti6Al4V ELI. System provides mechanical support to spine; stabilizes segments to facilitate fusion. Benefits patient by correcting deformities, stabilizing fractures, or addressing degenerative conditions. Output is physical stabilization of spinal segments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Ti6Al4V ELI (ISO 5832-3, ASTM F-136). Components: smooth rods, plates, screws (4.0-10.5mm diameter, 20-100mm length), hooks, nut screws, transverse links. Standards: ASTM F1717-04, ASTM F1798-97, ANSI/AAMI/ISO 17665-1. Mechanical fixation system; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring non-cervical spinal immobilization and stabilization as an adjunct to fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal deformities (scoliosis, kyphosis, lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion. Used as posterior pedicle screw (T1-S2), posterior hook (T1-L5), or anterolateral (T8-L5) fixation.

Regulatory Classification

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

GSS Pedicle Screw System (K053573)
Synthes Pangea System (K052123)
INCOMPASS SPINAL FIXATION SYSTEM (K021564)

Related Devices

K023498 — MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM · Blackstone Medical, Inc. · Nov 13, 2002
K011830 — TRI-FIX SPINAL FIXATION SYSTEM · Endius, Inc. · Jul 23, 2001
K981676 — CD HORIZON SPINAL SYSTEM · Sofamor Danek USA,Inc. · Jan 28, 1999
K120696 — TIGER SPINE SYSTEM · Corelink, LLC · Apr 2, 2012
K103091 — LANX SPINAL FIXATION SYSTEM · Lanx, Inc. · Apr 15, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ · Submitter: GS Medical Co., Ltd. . ・ ### 510(k) Summary . | Submitter Name: Submitter Address: | GS Medical Co., Ltd 12 F Kolon Digital Tower Aston, 505-14Gasan-Dong, Geumcheon-gu, Seoul, Korea | JAN 2 5 2010 | |--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Phone Number: | 82-2-2082-7777 | | | Fax Number: | 82-2-2082-7778 | | | Contact Person: | Dong Yong, Kim | | | Date Prepared: | June 3, 2009 | | | Device Trade Name: | AnyPlus Spinal Fixation System | | | Common Name | Spinal interlaminal fixation orthosis Spinal intervertebral body fixation orthosis Pedicle Screw spinal system | | | Classification Name, | Class II: appliance, fixation, spinal interlaminal, 888.3050, KWP | | | Number & Product Code: | Class II: appliance, fixation, spinal intervertebral body, 888.3060, KWQ | | | | Class II/Class III: orthosis, spondyloisthesis spinal fixation, 888.3070, MNH, MNI, NKB | | | Predicate Devices: | GSS Pedicle Screw System (K053573), Synthes Pangea System (K052123) INCOMPASS SPINAL FIXATION SYSTEM (K021564) | | | Device Description and Statement of Intended Use | Device Description: The AnyPlus Spinal Fixation System consists of various hooks, screws, rods and connectors and is intended to create a rigid spinal construct. A table of components can be found in Section 11. | | | | The AnyPlus Spinal Fixation System includes components from GSS Pedicle Screw System previously cleared in K053573. These components will keep their original cleared trade name. A table of components can be found in Section 11 identified as GSS Pedicle Screw System 510(k): K053573. | | | | The components are manufactured from Ti6Al4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). | | | | Specialized instruments are available for the application and removal of the Anypluss Spinal Fixation System. A table of components can be | | | | Intended Use: AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8- L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion | | | Summary of Technological Characteristics | AnyPlus Spinal Fixation System is made of devices for fixation of the non cervical spine. They include smooth rods, plates, screws, hooks, nut screws, transverse links. The components are manufactured from Ti6AI4V ELI according to ISO 5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mm diameters with lengths ranging from 20 to 100mm (Length does not include the screw head). | | | Conclusion | The information discussed above demonstrates that AnyPlus Spinal Fixation System, as effective, and performs as well as or better than the predicate devices. | | | Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. | | {1}------------------------------------------------ . found in Section 11. #### Summary of Technical Characteristics | Feature | AnyPlus Spinal Fixation System | GSS Pedicle Screw System | Synthes Pangea System | INCOMPASS SPINAL FIXATION SYSTEM | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K091717 | K053573 | K052123 | K021564 | | Manufacturer | GS MEDICAL CO., LTD. | GS MEDICAL CO., LTD. | SYNTHES (USA) | SPINAL CONCEPTS, INC | | Classification # & Product Code | 888.3050, 888.3060, 888.3070 KWP, KWQ, MNH, MNI | 888.3070 MNH, MNI | 888.3050, 888.3070 KWP, KWQ, MNH, MNI, NKB | 888.3060 KWP, KWQ, MNH, MNI | | Intended Use | AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system | The GSS Pedicle Screw System is a pedicle screw system indicated for the treatment of severe Spondylisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous | The Synthes USS (including the Click'X®, and USS VAS variable axis components, and Pangea™), Click'X® Monoaxial, Dual- Opening and the Small Stature USS (which | When intended for pedicle screw fixation from T1-S1, the InCompass Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature | . . {2}------------------------------------------------ --- # | (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion. | | bon graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the GSS Pedicle Screw System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). | | includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion. When treating patients with Degenerative Disc Disease (DDD), | transverse bars are not cleared for use as part of the posterior pedicle | 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, and failed previous fusion. As a pedicle screw system placed between L3 and S1, the indications include Grade 3 and 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. When intended for non-pedicle, posterior screw fixation of the non- cervical spine (T1- S1), the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoli osis with associated | paralysis or spasticity, scoliosis with deficient posterior elements | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| . {3}------------------------------------------------ ・ ---- #### AnyPlus Spinal Fixation System Premarket Notification: Traditional 510(k) | | screw construct. | such as that resulting from | | | | |--|-------------------|--------------------------------|--|---------------|---------------------------------------------------------| | | When used with | laminectomy or | | | | | | the 3.5/6.0 mm | myelomeningocele, | | | | | | parallel | spinal fractures | | | | | | connectors, the | (acute reduction or | | | | | | Synthes USS | late deformity), | | | | | | (including the | degenerative disc | | | | | | Click'X® and, | disease (back pain | | | | | | USS VAS variable | of discogenic origin | | | | | | axis components, | with degeneration of | | | | | | and Pangea™), | the disc confirmed | | | | | | Click'X® | by history and | | | | | | Monoaxial and | radiographic | | | | | | Dual-Opening | studies), tumor, | | | | | | USS can be linked | spondylolisthesis, | | | | | | to the CerviFix® | spinal stenosis and | | | | | | System. In | failed previous | | | | | | addition, when | fusion. | | | | | | used with 3.5/5.0 | | | | | | | mm parallel | When intended for | | | | | | connectors, the | anterolateral screw, | | | | | | Synthes Small | rod and or cable | | | | | | Stature USS can | fixation of the T6-L5 | | | | | | be linked to the | spine the indications | | | | | | Synthes USS | are degenerative | | | | | | (including the | disc disease | | | | | | Click'X®, and | disease (back pain | | | | | | USS VAS variable | of discogenic origin | | | | | | axis components, | with degeneration of | | | | | | and Pangea™), | the disc confirmed | | | | | | the Click'X® | by history and | | | | | | Monoaxial and | radiographic | | | | | | Dual-Opening | studies), | | | | | | USS Systems. | spondylolisthesis, | | | | | | | trauma (i.e. fracture | | | | | | In addition, | or dislocation), | | | | | | Synthes USS | spinal stenosis, | | | | | | (including the | deformities or | | | | | | Click'X®, and | curvatures (i.e. | | | | | | USS VAS variable | scoliosis, kyphosis, | | | | | | axis components, | and/or lordosis), | | | | | | and Pangea), | tumor and failed | | | | | | Click'X® | previous fusion. | | | | | | Monoaxial and | | | | | | | the Dual-Opening | The use of posterior | | | | | | USS can be | spinal | | | | | | interchanged with | instrumentation in | | | | | | all USS 6.0 mm | children has been | | | | | | rods and | reported in the | | | | | | transconnectors. | literature. The | | | | | | | InCompass Spinal | | | | | | | Fixation System | | | | | | | may be used for | | | | | | | non-pedicle | | | | | | | posterior use in this | | | | | | | patient group. | | | | | | | After solid fusion | | | | | | | | | occurs, these | occurs, these devices serve no functional purpose | {4}------------------------------------------------ #### AnyPlus Spinal Fixation System Premarket Notification: Traditional 510(k) | | | | | and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and patient, taking into consideration the patient's general medical condition and the potential risk to the patient for a second surgical procedure. | |---------------------------|---------------------------------------------------------------------------------------------------|------------------------------------|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Titanium Alloy (Ti- 6Al-4V ELI) | Titanium Alloy (Ti- 6Al-4V ELI) | Titanium Alloy | Titanium Alloy (Ti- 6Al-4V ELI) | | Standard of Conformity | ASTM F1717-04, ASTM F1798-97, ASTM F136-98, ISO 5832-3:1996, ANSI/AAMI/ISO 17665-1 | | | | . - {5}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head turned to the right. The bird is depicted in a simple, graphic style. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 GS Medical Co., Ltd. % Oserve America, Inc. Mr. William F. Greenrose President 220 River Road Claremont, New Hampshire 03743 ### JAN 2 5 2010 Re: K091717 Trade/Device Name: AnyPlus Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: January 10, 2010 Received: January 12, 2010 Dear Mr. Greenrose: 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 devices, 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 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 Federal 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {6}------------------------------------------------ Page 2 - Mr. William F. Greenrose device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Barbara Buehrig Mark N. Me Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K091717 Device Name: AnyPlus Spinal Fixation System Indications For Use: AnyPlus Spinal Fixation System are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (TB-L5). All components in the system are limited to skeletally mature patients. System components are to be used for immobilization and stabilization of the spine as an adjunct to fusion. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion. Prescription Use × (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) Concurrence of CDRH, Office of Device Evaluation (ODE) signature (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices K091717 510(k) Number_ Page 1 of 1 Section 4.0 CONFIDENTIAL