(228 days)
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.
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 found in Section 11.
The provided text describes a 510(k) summary for the "AnyPlus Spinal Fixation System," a medical device. This document does not describe a study involving "acceptance criteria" and "device performance" in the way one would typically expect for an AI/ML or diagnostic device. Instead, it focuses on demonstrating "substantial equivalence" of a spinal fixation system to predicate devices through technical characteristics and intended use.
Therefore, many of the requested elements are not applicable to the provided document. I will extract and describe the information that is present.
1. Table of Acceptance Criteria and Reported Device Performance
This section is Not Applicable in the context of the provided document. The document describes a spinal fixation system, not an AI/ML or diagnostic device with performance metrics like accuracy, sensitivity, or specificity. The submission aims to demonstrate "substantial equivalence" to predicate devices based on material, design, and intended use, rather than meeting specific performance acceptance criteria from a clinical study.
2. Sample Size Used for the Test Set and Data Provenance
This section is Not Applicable. The document is a 510(k) summary for a physical spinal fixation system. It does not involve a "test set" of data or data provenance in the context of device performance evaluation as would be relevant for an AI/ML device. The evaluation is based on technical specifications, material properties, and comparison to legally marketed predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is Not Applicable. There is no "ground truth" derived from experts in this context, as it is not a diagnostic or AI/ML device being evaluated. The evaluation relies on engineering principles, material science, and regulatory comparison.
4. Adjudication Method for the Test Set
This section is Not Applicable. There is no "test set" or adjudication process described for this type of medical device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is Not Applicable. MRMC studies are relevant for diagnostic devices (often involving human readers and AI assistance). The "AnyPlus Spinal Fixation System" is a physical implant, not a diagnostic tool or an AI-assisted interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is Not Applicable. This concept applies to AI/ML software. The device is a physical spinal fixation system, not an algorithm.
7. The Type of Ground Truth Used
This section is Not Applicable. As stated, there is no "ground truth" in the context of a diagnostic or AI/ML evaluation for this device. The regulatory approval is based on demonstrating substantial equivalence to predicate devices, material testing, and design specifications.
8. The Sample Size for the Training Set
This section is Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
This section is Not Applicable. As there is no training set mentioned, establishing ground truth for it is not relevant to this document.
Summary of Relevant Information from the Provided Text:
The document is a 510(k) summary for the AnyPlus Spinal Fixation System. The primary goal of this submission is to demonstrate substantial equivalence to predicate devices already on the market, rather than meeting specific performance acceptance criteria through a clinical study or AI/ML evaluation.
- Device Description: The AnyPlus Spinal Fixation System consists of various hooks, screws, rods, and connectors made from Ti6Al4V ELI (Titanium Alloy) according to ISO 5832-3 and ASTM F-136. It is intended to create a rigid spinal construct.
- Intended Use: Non-cervical spinal fixation for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5) in skeletally mature patients as an adjunct to fusion. Indications include degenerative disc disease, spondylolisthesis, trauma, deformities/curvatures, tumor, stenosis, pseudoarthrosis, and failed previous fusion.
- Predicate Devices:
- Demonstration of Equivalence: The submission argues that the AnyPlus Spinal Fixation System is "as effective, and performs as well as or better than the predicate devices" based on comparing technical characteristics (materials, components, intended use, and classification) to these predicate devices. The materials used (Titanium Alloy Ti-6Al-4V ELI) and compliance with standards (ASTM F1717-04, ASTM F1798-97, ASTM F136-98, ISO 5832-3:1996, ANSI/AAMI/ISO 17665-1) are highlighted as part of this demonstration.
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Submitter: GS Medical Co., Ltd.
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510(k) Summary
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| Submitter Name:Submitter Address: | GS Medical Co., Ltd12 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 orthosisSpinal intervertebral body fixation orthosisPedicle 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 Descriptionand Statement ofIntended Use | Device Description: The AnyPlus Spinal Fixation System consists ofvarious hooks, screws, rods and connectors and is intended to create arigid spinal construct. A table of components can be found in Section 11. | |
| The AnyPlus Spinal Fixation System includes components from GSSPedicle Screw System previously cleared in K053573. Thesecomponents will keep their original cleared trade name. A table ofcomponents can be found in Section 11 identified as GSS Pedicle ScrewSystem 510(k): K053573. | ||
| The components are manufactured from Ti6Al4V ELI according to ISO5832-3 and ASTM F-136. The screws are available from 4.0 to 10.5mmdiameters with lengths ranging from 20 to 100mm (Length does notinclude the screw head). | ||
| Specialized instruments are available for the application and removal ofthe Anypluss Spinal Fixation System. A table of components can be | ||
| Intended Use: AnyPlus Spinal Fixation System are non-cervical spinal fixationdevices intended for use as posterior pedicle screw fixation systems (T1-S2), aposterior 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 thespine as an adjunct to fusion. These devices are indicated for all of the followingindications regardless of the intended use: degenerative disc disease (definedas discogenic back pain with degeneration of the disc confirmed by history andradiographic 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 previousfusion | ||
| Summary ofTechnologicalCharacteristics | AnyPlus Spinal Fixation System is made of devices for fixation of thenon cervical spine. They include smooth rods, plates, screws, hooks, nutscrews, transverse links. The components are manufactured fromTi6AI4V ELI according to ISO 5832-3 and ASTM F-136. The screws areavailable from 4.0 to 10.5mm diameters with lengths ranging from 20 to100mm (Length does not include the screw head). | |
| Conclusion | The information discussed above demonstrates that AnyPlus SpinalFixation System, as effective, and performs as well as or better than thepredicate devices. | |
| Declarations | This summary includes only information that is also covered in the bodyof the 510(k).This summary does not contain any puffery or unsubstantiated labelingclaims. |
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found in Section 11.
Summary of Technical Characteristics
| Feature | AnyPlus SpinalFixation System | GSS Pedicle ScrewSystem | Synthes PangeaSystem | INCOMPASSSPINAL FIXATIONSYSTEM |
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| 510(k) Number | K091717 | K053573 | K052123 | K021564 |
| Manufacturer | GS MEDICALCO., LTD. | GS MEDICAL CO.,LTD. | SYNTHES(USA) | SPINALCONCEPTS, INC |
| Classification # &Product Code | 888.3050,888.3060,888.3070KWP, KWQ, MNH,MNI | 888.3070MNH, MNI | 888.3050,888.3070KWP, KWQ,MNH, MNI, NKB | 888.3060KWP, KWQ, MNH,MNI |
| Intended Use | AnyPlus SpinalFixation Systemare non-cervicalspinal fixationdevices intendedfor use as posteriorpedicle screwfixation systems(T1-S2), aposterior hookfixation system | The GSS PedicleScrew System is apedicle screw systemindicated for thetreatment of severeSpondylisthesis(Grade 3 and 4) ofthe L5-S1 vertebra inskeletally maturepatients receivingfusion by autogenous | The Synthes USS(including theClick'X®, andUSS VAS variableaxis components,and Pangea™),Click'X®Monoaxial, Dual-Opening and theSmall StatureUSS (which | When intended forpedicle screwfixation from T1-S1,the InCompassSpinal FixationSystem is intendedto provideimmobilization andstabilization ofspinal segments inskeletally mature |
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| (T1-L5), or as aanterolateralfixation system(T8-L5). Pediclescrew fixation islimited to skeletallymature patients.These devices areindicated for all ofthe followingindicationsregardless of theintended use:degenerative discdisease (definedas discogenic backpain withdegeneration ofthe disc confirmedby history andradiographicstudies),spondylolisthesis,trauma (i.e.,fracture ordislocation),deformities orcurvatures (i.e.,scoliosis, kyphosis,and/or lordosis,Scheuermann'sDisease), tumor,stenosis,pseudoarthrosis,and failed previousfusion. | bon graft havingimplants attached tothe lumbar and sacralspine (L3 to sacrum)with removal of theimplants after theattainment of a solidfusion.In addition, the GSSPedicle ScrewSystem is intended toprovideimmobilization andstabilization of spinalsegments in skeletallymature patients as anadjunct to fusion inthe treatment of thefollowing acute andchronic instabilities ordeformities of thethoracic, lumbar andsacral spine:degenerativeSpondylolisthesis withobjective evidence ofneurologicalimpairment, fracture,dislocation, scoliosis,kyphosis, spinaltumor and failedprevious fusion(pseudarthrosis). | includes smallstature andpediatric patients)are non-cervicalspinal fixationdevices intendedfor use asposterior pediclescrew fixationsystems (T1-S2),a posterior hookfixation system(T1-L5), or as aanterolateralfixation system(T8-L5). Pediclescrew fixation islimited toskeletally maturepatients with theexception of theSmall StatureUSS. Thesedevices areindicated for all ofthe followingindicationsregardless of theintended use:degenerative discdisease (definedas discogenicback pain withdegeneration ofthe disc confirmedby history andradiographicstudies),spondylolisthesis,trauma (i.e.,fracture ordislocation),deformities orcurvatures (i.e.,scoliosis,kyphosis, and/orlordosis,Scheuermann'sDisease), tumor,stenosis,pseudoarthrosis,and failedprevious fusion.When treatingpatients withDegenerative DiscDisease (DDD), | transverse bars are not cleared for use as part of the posterior pedicle | patients as anadjunct to fusion inthe treatment of thefollowing acute andchronic instabilitiesor deformities of thethoracic, lumbar andsacral spine:degenerative discdisease (defined asdiscogenic backpain withdegeneration of thedisc confirmed byhistory andradiographicstudies),degenerativespondylolisthesiswith objectiveevidence ofneurologicimpairment,fracture, dislocation,deformities orcurvatures (i.e.,scoliosis, kyphosis,and/or lordosis),tumor, and failedprevious fusion.As a pedicle screwsystem placedbetween L3 and S1,the indicationsinclude Grade 3 and4 spondylolisthesis,when utilizingautologous bonegraft, when affixedto the posteriorlumbosacral spine,and intended to beremoved after solidfusion isestablished.When intended fornon-pedicle,posterior screwfixation of the non-cervical spine (T1-S1), the indicationsare idiopathicscoliosis,neuromuscularscoliosis/kyphoscoliosis with associated | paralysis or spasticity, scoliosis with deficient posterior elements | ||
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| ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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AnyPlus Spinal Fixation System Premarket Notification: Traditional 510(k)
| screw construct. | such as thatresulting 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, thesedevices serve nofunctional purpose |
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AnyPlus Spinal Fixation System Premarket Notification: Traditional 510(k)
| and should beremoved. In mostcases, removal isindicated becausethe implants are notintended to transferor support forcesdeveloped duringnormal activities.Any decision toremove the devicemust be made bythe physician andpatient, taking intoconsideration thepatient's generalmedical conditionand the potentialrisk to the patient fora second surgicalprocedure. | ||||
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| Material | Titanium Alloy (Ti-6Al-4V ELI) | Titanium Alloy (Ti-6Al-4V ELI) | Titanium Alloy | Titanium Alloy (Ti-6Al-4V ELI) |
| Standard ofConformity | ASTM F1717-04,ASTM F1798-97,ASTM F136-98,ISO 5832-3:1996,ANSI/AAMI/ISO17665-1 |
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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
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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
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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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
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.
(b)
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.