(85 days)
The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine for the following indications: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion.
The Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker Spine Trio® Spinal Fixation System is indicated for: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion. The Trio® Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.
The Stryker Spine Trio®+ Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine. The Stryker SpineTrio®+ Spinal System is indicated for: Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion. The Trio + Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, Xia " Pre-bent Rods, and the Multi-Axis Cross Connectors.
The Stryker Spine Trio® Plate System is comprised of spinal screws, plates and locking components, fabricated from Titanium alloy.
The Stryker Spine Trio® Spinal Fixation System is comprised of spinal screws, rods, and offset connectors, fabricated from Titanium alloy.
The Stryker Spine Trio®+ Spinal System contains spinal screws, rods, and connectors, fabricated from Titanium alloy.
The provided submission does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.
This document describes a 510(k) premarket notification for the Stryker Spine Trio® Plate System, Trio® Spinal Fixation System, and Trio®+ Spinal System. This is a traditional medical device (spinal fixation system) and not an AI/ML-based device. The "study" mentioned refers to mechanical testing in compliance with FDA's Guidance for Spinal System 510(k)s, not a clinical study involving human or AI performance evaluation.
Therefore, the requested information elements related to AI/ML device performance (like sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable to this submission.
Here's a breakdown based on the characteristics of this traditional medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (N/A for AI/ML) | Reported Device Performance (N/A for AI/ML) |
|---|---|---|
| Material Properties | Compatibility with Titanium alloy standards, mechanical strength, fatigue resistance. | Implied: Passed mechanical testing, demonstrating sufficient strength and durability as per FDA guidance for spinal systems. The device is fabricated from Titanium alloy. |
| Biocompatibility | Biocompatibility with human tissue. | Implied: Met biocompatibility standards for implantable devices made of Titanium alloy, as it's a predicate-based submission. |
| Sterilization | Ability to be sterilized. | Implied: Sterilization methods are suitable for the device as an implantable medical device. |
| Functional Equivalence | Equivalent mechanical performance to predicate devices. | Stated: "Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed... and was presented in their respective predicate 510(k)s." |
| Indications for Use | Expanded Class III indications (NKB) are appropriate and consistent with predicate devices and FDA guidance. | Stated: The submission "addresses the additional Class III indications associated with product code NKB." The expanded indications were "modeled on the suggested indications for use statement for posterior thoracolumbar systems... suggested by FDA in FDA's 'Guidance for Industry and FDA Staff: Spinal System 510(k)s,' dated May 3, 2004." |
Explanation: For this type of traditional spinal implant, the "acceptance criteria" are primarily established through bench testing (mechanical, material, biocompatibility) to demonstrate substantial equivalence to predicate devices and adherence to relevant FDA guidance and recognized standards. The submission highlights that no new components are being introduced; rather, it is seeking approval for additional Class III indications based on existing predicate device testing and FDA guidance. There is no performance reported in terms of diagnostic accuracy or clinical outcomes of the device itself beyond its mechanical integrity and intended use alignment.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a traditional spinal fixation system, not an AI/ML device that would have a "test set" of data in the AI/ML context. The testing referenced is bench/mechanical testing to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/ML sense. For this device, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science, and the functional performance of predicate devices in accordance with FDA guidance for spinal systems. It's about meeting mechanical and material performance specifications rather than diagnostic truth.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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010368
Traditional 510(k) Premarket Notification
Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System
Stryker Spine Submitter: 2 Pearl Court Allendale, New Jersey 07401 Ms. Simona Voic Contact Person Regulatory Affairs Project Manager Phone: 201-760-8145 FAX: 201-760-8345 Email: simona.voic@stryker.com April 17, 2007 Date Prepared Stryker Spine Trio® Plate System Trade Name Class III Proposed Class Pedicle Screw Spinal System Classification Name [21 CFR 888.3070(b) (1) & (b) (2)] and Number NKB, MNH, and MNI Product Code K043180 - Stryker Spine Trio® Plate System (PS) Predicate Devices K060361 - Stryker Spine Xia® and Xia ® 4.5 Spinal Systems K060369 - Stryker Spine Opus™ Spinal System The Stryker Spine Trio® Plate System is comprised of spinal Device Description screws, plates and locking components, fabricated from Titanium alloy.
510(k) Summary of Safety and Effectiveness Stryker Spine Trio® Plate System
MAY - 4 2007
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| This submission adds the Class III indications per product code | |
|---|---|
| NKB, 21 CFR 888.3070(b)(2), but no additional components. | |
| The expanded indications for use statement for the TRIO® PS | |
| has also been modeled on the suggested indications for use | |
| statement for posterior thoracolumbar systems (product codes | |
| MNI, MNH, NKB) suggested by FDA in FDA's "Guidance for | |
| Industry and FDA Staff: Spinal System 510(k)s," dated May 3, | |
| 2004. | |
| Intended Use | The Stryker Spine Trio® Plate System is intended for posterior, |
| noncervical (T10-S1) pedical and nonpedical fixation of the | |
| spine for the following indications: | |
| Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e., fracture or dislocation); Spinal stenosis; Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); Tumor; Pseudoarthrosis; and Failed previous fusion. | |
| Summary of the | Testing in compliance with FDA's Guidance for Spinal System |
| Technological | 510(k)'s May 3, 2004 was performed for the Stryker Spine Trio® |
| Characteristics | Plate System and was presented in their respective predicate |
| 510(k)s. This 510(k) contains no new components. It only | |
| addresses the additional Class III indications associated with | |
| product code NKB. |
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:
:
Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System
| 510(k) Summary of Safety and Effectiveness |
|---|
| Stryker Spine Trio® Spinal Fixation System |
.
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
|---|---|
| Contact Person | Ms. Simona VoicRegulatory Affairs Project ManagerPhone: 201-760-8145FAX: 201-760-8345Email: simona.voic@stryker.com |
| Date Prepared | April 17, 2007 |
| Trade Name | Trio® Spinal Fixation System |
| Proposed Class | Class III |
| Classification Nameand Number | Pedicle Screw Spinal System21 CFR 888.3070(b) (1) & (b) (2) |
| Product Code | NKB, MNH, and MNI |
| Predicate Devices | K032855 – Stryker Spine MAPS SystemK052971 - Stryker Spine Trio® Spinal Fixation SystemK060361 - Stryker Spine Xia® and Xia ® 4.5 Spinal Systems |
| Device Description | The Stryker Spine Trio® Spinal Fixation System is comprised ofspinal screws, rods, and offset connectors, fabricated fromTitanium alloy. |
| This submission adds the Class III indications per product code | |
| NKB, 21 CFR 888.3070(b)(2), but no additional components. | |
| The expanded indications for use statement for the TRIO® | |
| Spinal Fixation System has also been modeled on the suggested | |
| indications for use statement for posterior thoracolumbar | |
| systems (product codes MNI, MNH, NKB) suggested by FDA in | |
| FDA's "Guidance for Industry and FDA Staff: Spinal System | |
| 510(k)s," dated May 3, 2004. | |
| Intended Use | The Stryker Spine Trio® Spinal Fixation System is intended for |
| posterior, noncervical pedicle and non-pedicle fixation of the spine. | |
| The Stryker Spine Trio® Spinal Fixation System is indicated for: | |
| Degenerative disc disease (DDD) (defined as back pain ofdiscogenic origin with degeneration of the disc confirmed byhistory and radiographic studies); | |
| Spondylolisthesis; | |
| Trauma (i.e., fracture or dislocation); | |
| Spinal stenosis; | |
| Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); | |
| Tumor; | |
| Pseudoarthrosis; and | |
| Failed previous fusion. | |
| The Trio® Spinal Fixation System is intended to be used in | |
| conjunction with the OSS Diapason Rods, Opus Spinal SystemRods, and the Multi-Axis Cross Connectors. | |
| Summary of the | Testing in compliance with FDA's Guidance for Spinal System |
| Technological | 510(k)'s May 3, 2004 was performed for the Stryker Spine Trio® |
| Characteristics | Spinal Fixation System and presented in K032855 and K052971. |
| This 510(k) contains no new components. It only addresses the | |
| additional Class III indications associated with product code | |
| NKB. | |
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.
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Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System
510(k) Summary of Safety and Effectiveness Stryker Spine Trio®+ Spinal System
| Submitter: | Stryker Spine2 Pearl CourtAllendale, New Jersey 07401 |
|---|---|
| Contact Person | Ms. Simona VoicRegulatory Affairs Project ManagerPhone: 201-760-8145FAX: 201-760-8345Email: simona.voic@stryker.com |
| Date Prepared | April 17, 2007 |
| Trade Name | Stryker Spine Trio®+ Spinal System |
| Proposed Class | Class III |
| Classification Nameand Number | Pedicle Screw Spinal System21 CFR 888.3070(b) (1) & (b) (2) |
| Product Code | NKB, MNH, and MNI |
| Predicate Devices | K052971 - Stryker Spine Trio® Spinal Fixation SystemK062698 - Stryker Spine Trio®+ Spinal SystemK060361 – Stryker Spine Xia® and Xia® 4.5 Spinal Systems |
| Device Description | The Stryker Spine Trio®+ Spinal System contains spinal screws,rods, and connectors, fabricated from Titanium alloy. Thissubmission adds the Class III indications per product code NKB, |
| 21 CFR 888.3070(b)(2), but no additional components. | |
| The expanded indications for use statement for the TRIO® + | |
| Spinal System has also been modeled on the suggested | |
| indications for use statement for posterior thoracolumbar | |
| systems (product codes MNI, MNH, NKB) suggested by FDA in | |
| FDA's "Guidance for Industry and FDA Staff: Spinal System | |
| 510(k)s," dated May 3, 2004. | |
| Intended Use | The Stryker Spine Trio®+ Spinal System is intended for |
| posterior, noncervical pedicle and non-pedicle fixation of the | |
| spine. | |
| The Stryker Spine Trio®+ Spinal System is indicated for: | |
| Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); | |
| Spondylolisthesis; | |
| Trauma (i.e., fracture or dislocation); | |
| Spinal stenosis; | |
| Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); | |
| Tumor; | |
| Pseudoarthrosis; and | |
| Failed previous fusion. | |
| The Trio®+ Spinal System is intended to be used in conjunction | |
| with the OSS Diapason Rods, Opus Spinal System Rods, Xia® | |
| Pre-bent Rods, and the Multi-Axis Cross Connectors. | |
| Summary of theTechnologicalCharacteristics | Testing in compliance with FDA's Guidance for Spinal System510(k)'s May 3, 2004 was performed for the Stryker SpineTrio®+ Spinal System, and was presented in the respectivepredicate 510(k)s. This 510(k) contains no new components. Itonly addresses the additional Class III indications associatedwith product code NKB. |
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K 0 70368
3 of 3
Traditional 510(k) Premarket Notification
Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System
{7}------------------------------------------------
Public Health Service
Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Spine Corporation c/o Ms. Simona Voic 2 Pearl Court Allendale, New Jersey 07401
MAY - 4 2007
Re: K070368
Trade Name: TRIO® Plate System, TRIO® Spinal Fixation System, TRIO®+ Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNH,MNI Dated: April 13, 2007 Received: April 17, 2007
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the device are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they 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 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 devices comply 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); 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.
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Page 2 - Mr. Christopher Klaczyk
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Mueller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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& Trio®+ Spinal System
Indications for Use
510(k) Number (if known): K070368
Device Name: Stryker Spine Trio® Plate System
Indications For Use:
The Stryker Spine Trio® Plate System is intended for posterior, noncervical (T10-S1) pedical and nonpedical fixation of the spine for the following indications:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis; .
- Trauma (i.e., fracture or dislocation); .
- Spinal stenosis; .
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor; .
- Pseudoarthrosis; and .
- Failed previous fusion. ●
AND/OR Over-The-Counter Use Prescription Use X____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Saubare Breechup
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K070368
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Indications for Use
510(k) Number (if known): K070368 Device Name: Stryker Spine Trio® Spinal Fixation System
Indications For Use:
The Stryker Spine Trio® Spinal Fixation System is intended for posterior, noncervical pedicle and non-pedicle fixation of the spine.
The Stryker Spine Trio® Spinal Fixation System is indicated for:
- . Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis; .
- Trauma (i.e., fracture or dislocation); .
- Spinal stenosis; .
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor; .
- Pseudoarthrosis; and .
- Failed previous fusion. .
The Trio® Spinal Fixation System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, and the Multi-Axis Cross Connectors.
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,
Jaubare Bouenn
Division Sign Off
Division of General, Restorati and Neurological Devices
Page 1 of 1
510(k) Number K070368
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Stryker Spine Trio® PS, Trio® Spinal Fixation System & Trio®+ Spinal System
Indications for Use
510(k) Number (if known): K070368 Device Name: Stryker Spine Trio + Spinal System
Indications For Use:
The Stryker Spine Trio 4 Spinal System is intended for posterior, noncervical pedicle and nonpedicle fixation of the spine.
The Stryker SpineTrio®+ Spinal System is indicated for:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- . Spondylolisthesis;
- Trauma (i.e., fracture or dislocation); .
- Spinal stenosis; .
- Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- Tumor; #
- Pseudoarthrosis; and
- Failed previous fusion. .
The Trio + Spinal System is intended to be used in conjunction with the OSS Diapason Rods, Opus Spinal System Rods, Xia " Pre-bent Rods, and the Multi-Axis Cross Connectors.
Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)
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
Division of General. Resto and Neurological Devices
Page 1 of 1
510(k) Number K070368
§ 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.