(34 days)
The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/lium) and nonpedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (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 in skeletally mature patients.
The M.U.S.T. Extension - Straight Connectors and Additional Screws are intended to be used as part of the M.U.S.T. Pedicle Screws System (K121118, K132878, K141988, K153664) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screws System includes: cannulated or non-cannulated poly-axial pedicle screws (K121115and K132878), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), cross connectors (K132878), enhanced screws and rods designed for percutaneous surgery (K141988), and cannulated or non-cannulated reduction screws (K153664). The M.U.S.T. Additional Pedicle Screws (standard and enhanced pedicle) are made of Ti6Al4V ELI (ISO 5832-3, ASTM F136-13) and CoCrMo (ISO 5832-12, ASTM F1537-11), while the M.U.S.T. Additional Reduction Screws are made of Ti6A14V ELI (ISO 5832-3, ASTM F136-13). The screw shaft is color anodized to simplify the identification of the screw diameter. The pedicle screw has a dual lead thread to simplify the screw insertion and reduce the number of turns. The threads are designed with a cylindrical diameter. The M.U.S.T. Straight Connectors and Additional Screws introduces the following additional components: Pedicle screw, Enhanced Solid Pedicle screw, Enhanced Cannulated Pedicle screw, Reduction Pedicle screw, Reduction Cannulated Pedicle screw, Straight Cross Connector.
The provided document is a 510(k) Premarket Notification for the M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance testing.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list specific numerical acceptance criteria. Instead, it states that the acceptance criteria were "pre-defined" and "based on the standards, FDA guidance, and comparison to the predicate device system." The reported device performance is a general statement that the device "met all acceptance criteria" and "is substantially equivalent to the predicate devices."
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance (Dynamic Compression Bending) | Performance equivalent to predicate devices as determined by ASTM F1717-12, considering worst-case device. | Met all acceptance criteria. Performance substantially equivalent to predicate devices. |
| Mechanical Performance (Static Compression Bending) | Performance equivalent to predicate devices as determined by ASTM F1717-12, considering worst-case device. | Met all acceptance criteria. Performance substantially equivalent to predicate devices. |
| Mechanical Performance (Static Torsion) | Performance equivalent to predicate devices as determined by ASTM F1717-12, considering worst-case device. | Met all acceptance criteria. Performance substantially equivalent to predicate devices. |
| Biocompatibility | Material and manufacturing process identical to predicate devices, supporting biological safety. | Deemed unnecessary to conduct additional testing as materials and manufacturing are identical to predicate devices. |
| Technological Characteristics | New diameters and straight connector do not raise new questions of safety or effectiveness compared to predicates. | A comparison evaluation shows no new risks associated with the subject device design. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document repeatedly mentions "the worst-case device" for each of the mechanical tests (Dynamic Compression Bending, Static Compression Bending, Static Torsion). This implies a very small sample size, potentially a single representative device or a small set of devices configured to represent the most challenging conditions. The exact number is not explicitly stated.
- Data Provenance: The study is a laboratory-based mechanical testing study, not a clinical study involving human or animal data. Therefore, concepts like country of origin, retrospective, or prospective do not apply in the typical sense. It is an engineering verification study.
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)
This section is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1717-12) and the inherent physical properties and design specifications of the device, rather than expert judgment or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretations of data (e.g., imaging, clinical assessments). For mechanical testing, the "adjudication" is inherent in the adherence to established test standards and the objective measurement of physical properties.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable to this device. This type of study evaluates the performance of AI-assisted diagnostic or classification systems in a clinical context, often involving human readers interpreting medical images. The M.U.S.T. Pedicle Screw System Extension is a physical orthopedic implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (in the context of AI algorithms) is not applicable to this device. This device is a physical implant and does not involve any AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance data in this document is based on engineering standards and specifications. Specifically, the mechanical tests were performed according to ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The acceptance criteria were based on these standards, FDA guidance, and comparison to the predicate device's established performance.
8. The sample size for the training set
This question is not applicable as there is no "training set" in the context of a physical device mechanical performance study. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2017
Medacta International SA % Elizabeth Rose Manager, Regulatory Affairs Mapi USA. Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K171170
Trade/Device Name: M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class III Product Code: NKB, KWQ, KWP Dated: April 20, 2017 Received: April 21, 2017
Dear Ms. Rose:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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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 devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171170
Device Name
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
Indications for Use (Describe)
The M.U.S.T. Pedicle Screw System is intended for posterior non-cervical pedicle fixation (T1-S2/lium) and nonpedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (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 in skeletally mature patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory Affairs Manager Consultant: Elizabeth Rose, Regulatory Affairs Manager at Mapi USA, Inc. Date Prepared: April 20, 2017 Date Revised: May 23, 2017
II. Device
| Device Proprietary Name: | M.U.S.T. Pedicle Screw System Extension - StraightConnectors and Additional Screws | |
|---|---|---|
| Common or Usual Name: | Pedicle Screw Spinal System | |
| Classification Name: | Thoracolumbosacral Pedicle Screw Spinal System | |
| Primary Product Code: | NKB | |
| Secondary Product Code: | KWQ, KWP | |
| Regulation Number: | 21 CFR 888.3070, 21 CFR 888.3060, 21 CFR 888.3050 | |
| Device Classification | 2 |
Predicate Device III.
Substantial equivalence is claimed to the following devices:
Primary Predicate:
-
M.U.S.T. Pedicle Screws System, K121115, Medacta International SA
Additional Predicates: -
M.U.S.T. Extension, K132878, Medacta International SA (also known as M.U.S.T. Pedicle Screws System)
-
. M.U.S.T. Pedicle Screws System, K141988, Medacta International SA
-
M.U.S.T. Pedicle Screws System, K153664, Medacta International SA
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IV. Device Description
The M.U.S.T. Extension - Straight Connectors and Additional Screws are intended to be used as part of the M.U.S.T. Pedicle Screws System (K121118, K132878, K141988, K153664) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. Pedicle Screws System includes: cannulated or non-cannulated poly-axial pedicle screws (K121115and K132878), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115), straight and pre-bent rods (K121115), cross connectors (K132878), enhanced screws and rods designed for percutaneous surgery (K141988), and cannulated or non-cannulated reduction screws (K153664).
The M.U.S.T. Additional Pedicle Screws (standard and enhanced pedicle) are made of Ti6Al4V ELI (ISO 5832-3, ASTM F136-13) and CoCrMo (ISO 5832-12, ASTM F1537-11), while the M.U.S.T. Additional Reduction Screws are made of Ti6A14V ELI (ISO 5832-3, ASTM F136-13). The screw shaft is color anodized to simplify the identification of the screw diameter. The pedicle screw has a dual lead thread to simplify the screw insertion and reduce the number of turns. The threads are designed with a cylindrical diameter.
| Component | Diameter | Length | Material |
|---|---|---|---|
| Pedicle screw(Sterile and non-sterile) | 4 mm | 20 - 50 mm | Ti6Al4V ELIandCoCrMo |
| Enhanced SolidPedicle screw(Sterile and non-sterile) | 4 mm | 20 - 50 mm | Ti6Al4V ELIandCoCrMo |
| Enhanced CannulatedPedicle screw(Sterile and non-sterile) | 4.5 mm | 20 - 50 mm | Ti6Al4V ELIandCoCrMo |
| Reduction Pediclescrew (Sterile andnon-sterile) | 4 mm | 20 - 50 mm | Ti6Al4V ELI |
| Reduction CannulatedPedicle screw(Sterile and non-sterile) | 4.5 mm | 20 - 50 mm | Ti6Al4V ELI |
| Straight CrossConnector | N/A | 20–100 mm | Ti6Al4V ELIandCoCrMo |
The M.U.S.T. Straight Connectors and Additional Screws introduces the following additional components:
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V. Indications for Use
The M.U.S.T. Pedicle Screws System is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (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, and/or lordosis); tumor; pseudoarthrosis and failed previous fusion in skeletally mature patients.
VI. Comparison of Technological Characteristics
The M.U.S.T. Extension - Straight Connectors and Additional Screws and the predicate devices share the following characteristics:
- . indications for use;
- design screws only; ●
- materials - screws only;
- packaging;
- sterile.
The M.U.S.T. Extension - Straight Connectors and Additional Screws are technologically different from the predicate devices as follows:
- . new diameters added;
- addition of a straight connector;
- materials - straight connector.
The M.U.S.T. Extension - Straight Connectors and Additional Screws components are manufactured from Titanium-6Aluminum-4Vanadium Extra Low Interstitial Alloy (ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy and ASTM F136-13 Standard Specification For Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy For Surgical Implant Applications) and Cobalt-Chromium-Molybdenum alloy (Co-Cr-Mo) (ISO 5832-12 Second Edition 2007-05-01: Implants For Surgery -- Metallic Materials -- Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy [Including: Technical Corrigedum 1 (2008)] and ASTM F1537-11 Standard Specification for Wrought Cobalt-28Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539).
Biocompatibility testing was conducted on the predicate devices for the same material and testing supports the biological safety of the M.U.S.T. Extension - Straight Connectors and Additional Screws. Additional biocompatibility testing was deemed unnecessary because the materials and manufacturing process are identical to the predicate devices described below.
A comparison of the subject and predicate devices are provided in the tables below:
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| Parameters | M.U.S.T. Extension - PedicleScrew(Subject Device) | M.U.S.T. Pedicle ScrewK121115 and K124034(Predicate Device) |
|---|---|---|
| Design/Types | Posterior fixation devices to beused with rods and set screws | Identical |
| Material | Ti6Al4V ELICoCrMo | Identical |
| Diameter | 4.0 mm | 4.5 – 10 mm |
| Length | 20 - 50 mm | 20 – 100 mm |
| Device usage | Single Use | Identical |
| Shelf Life | 5 years | Identical |
| Biocompatibility | Implant with permanent >30 day | Identical |
| Sterilization | Sterile: GammaNon-sterile | Identical |
| Packaging | Individual packaging | Identical |
Technological comparison
| Parameters | M.U.S.T. Extension - SolidEnhanced Pedicle Screw(Subject Device) | M.U.S.T. Solid Enhanced PedicleScrewK141988(Predicate Device) |
|---|---|---|
| Design/Types | Posterior fixation devices to beused with rods and set screws | Identical |
| Material | Ti6Al4V ELICoCrMo | Identical |
| Diameter | 4.0 mm | 4.5 - 7 mm |
| Length | 20 – 50 mm | 20 – 90 mm |
| Device usage | Single Use | Identical |
| Shelf Life | 5 years | Identical |
| Biocompatibility | Implant with permanent >30 day | Identical |
| Sterilization | Sterile: GammaNon-sterile | Identical |
| Packaging | Individual packaging | Identical |
| Parameters | M.U.S.T. Extension - CannulatedEnhanced Pedicle Screw(Subject Device) | M.U.S.T. Cannulated EnhancedPedicle ScrewK141988(Predicate Device) |
|---|---|---|
| Design/Types | Posterior fixation devices to beused with rods and set screws | Identical |
| Material | Ti6Al4V ELICoCrMo | Identical |
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| Parameters | M.U.S.T. Extension - CannulatedEnhanced Pedicle Screw(Subject Device) | M.U.S.T. Cannulated EnhancedPedicle ScrewK141988(Predicate Device) |
|---|---|---|
| Diameter | 4.5 mm | 5 – 7 mm |
| Length | 20 – 50 mm | 20 – 90 mm |
| Device usage | Single Use | Identical |
| Shelf Life | 5 years | Identical |
| Biocompatibility | Implant with permanent >30 day | Identical |
| Sterilization | Sterile: Gamma | Identical |
| Non-sterile | ||
| Packaging | Individual packaging | Identical |
| Parameters | M.U.S.T. Extension - SolidReduction Pedicle Screw(Subject Device) | M.U.S.T. Solid Reduction PedicleScrewK153664(Predicate Device) |
|---|---|---|
| Design/Types | Posterior fixation devices to beused with rods and set screws | Identical |
| Material | Ti6Al4V ELI | Identical |
| Diameter | 4.0 mm | 4.5 - 7 mm |
| Length | 20 – 50 mm | 20 – 90 mm |
| Device usage | Single Use | Identical |
| Shelf Life | 5 years | Identical |
| Biocompatibility | Implant with permanent >30 day | Identical |
| Sterilization | Sterile: GammaNon-sterile | Identical |
| Packaging | Individual packaging | Identical |
| Parameters | M.U.S.T. Extension - CannulatedReduction Pedicle Screw(Subject Device) | M.U.S.T. Cannulated ReductionPedicle ScrewK153664(Predicate Device) |
|---|---|---|
| Design/Types | Posterior fixation devices to beused with rods and set screws | Identical |
| Material | Ti6Al4V ELI | Identical |
| Diameter | 4.5 mm | 5 - 7 mm |
| Length | 20 – 50 mm | 25 – 90 mm |
| Device usage | Single Use | Identical |
| Shelf Life | 5 years | Identical |
| Biocompatibility | Implant with permanent >30 day | Identical |
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| Parameters | M.U.S.T. Extension - CannulatedReduction Pedicle Screw(Subject Device) | M.U.S.T. Cannulated ReductionPedicle ScrewK153664(Predicate Device) |
|---|---|---|
| Sterilization | Sterile: GammaNon-sterile | Identical |
| Packaging | Individual packaging | Identical |
| Parameters | M.U.S.T. Extension - StraightConnectors(Subject Device) | M.U.S.T. Cross ConnectorsK132878(Predicate Device) |
|---|---|---|
| Design/Types | Posterior fixation devices to beused with rods and set screws | Identical |
| Material | Ti6Al4V ELICoCrMo | Ti6Al4V ELI |
| Length | 20 – 50 mm | 20 – 90 mm |
| Device usage | Single Use | Identical |
| Shelf Life | 5 years | Identical |
| Biocompatibility | Implant with permanent >30 day | Identical |
| Sterilization | Sterile: GammaNon-sterile | Identical |
| Packaging | Individual packaging | Identical |
| Additionaltechnicalfeatures | Length is not adjustable | Length is adjustable from 35 – 98mm |
Discussion
As seen above, the differences between the subject and predicate devices are the addition of new screw diameters (4.0 mm for solid screws and 4.5 mm for cannulated screws) to the range of sizes and the addition of a straight connector. These technological differences do not raise new questions of safety or effectiveness. A comparison evaluation shows there are no new risks associated with the subject device design.
VII. Performance Data
The addition of the subject devices was evaluated by risk analysis to identify any new risks associated with the extension of the pedicle screw sizes and the inclusion of the straight connectors. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and predefined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system.
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The M.U.S.T. Extension - Straight Connectors and Additional Screws was tested per ASTM F1717-12 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model using the worst-case device for each of the following tests:
-
- Dynamic Compression Bending
-
- Static Compression Bending
-
- Static Torsion
The testing met all acceptance criteria and verifies that the performance of the M.U.S.T. Extension - Straight Connectors and Additional Screws is substantially equivalent to the predicate devices.
VIII. Conclusion
The information provided above supports that the M.U.S.T. Extension - Straight Connectors and Additional Screws are as safe and effective as the predicate devices. Therefore, it is concluded that the M.U.S.T. Extension - Straight Connectors and Additional Screws is substantially equivalent to the predicate devices.
§ 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.