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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Description

The M.U.S.T. Extension and M.U.S.T. Long Tab is intended to be used as part of the M.U.S.T. Pedicle Screw system (K121115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system includes cannulated or non-cannulated poly-axial pedicle screws (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K121115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).

The M.U.S.T. Extension and M.U.S.T. Long Tab introduce new sizes of sterile implantable devices intended to be used for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The devices subject of this submission are:

New size of Straight Rods (both Titanium and CoCr version): length 600mm Hex interface at the end
New size of Straight Rods (Anodized Titanium version): length 600mm
Pre-contoured Rods (both Titanium and CoCr version)
New sizes of Lateral Connectors: length 80; 100; 125 & 150mm
New sizes of Enhanced Cannulated Pedicle Screws: Ø8; Ø9; Ø10 length from 30 to 100mm
New cannulated pedicle screws with thread 4 leads (15 and 25 mm)
Setscrews in Titanium

AI/ML Overview

This document is a 510(k) Premarket Notification from Medacta International SA for their M.U.S.T. Pedicle Screw Extension and Long Tab Implants. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed clinical study data on device performance against specific acceptance criteria for AI/ML-enabled devices.

Therefore, the requested information regarding acceptance criteria, study details, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment cannot be found in the provided text. The document describes a traditional medical device submission (pedicle screws) which relies on bench testing and comparison to predicates, not AI/ML performance studies.

However, based on the structure of the provided document, I can infer the "acceptance criteria" and "study" are related to the engineering and design validation of the medical device, rather than the performance of an AI/ML algorithm.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document describes several non-clinical studies and tests with implied acceptance criteria, but it does not present them in a clear table format with specific quantitative performance results against those criteria. Instead, it lists the types of tests performed.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Design Validation:	Design Validation:
Sufficient fixation in bone (Geometrical Analysis MUST LT Thread Geometry)	A geometrical analysis was performed in comparison to approved and marketed implants, related to the most important dimensions of the threads (assumed to meet acceptance criteria through comparison).
Operability with MIS percutaneous technique (Cadaver surgery)	Cadaver surgery performed according to the well-known MIS percutaneous technique by experienced surgeons (assumed successful operation; no specific outcome metrics provided).
Sufficient flexural strength of the tulip (Tab welding MUST LT Flexion strength test)	Flexion strength test performed to characterize the specific design of the tulip in the dedicated breaking area (assumed to meet acceptance criteria for breaking area design; no explicit quantitative results provided).
Performance Testing:	Performance Testing:
Adequate mechanical performance under static and dynamic axial compression (ASTM F1717-18)	Mechanical evaluation performed according to ASTM F1717-18 (Endolab 970 200220 30 1413 part 1 rev.0 and 970 200220 30 1414 part 1 rev.0) for worst-case definition (assumed to demonstrate acceptable mechanical performance comparable to predicate; no specific quantitative results provided).
Adequate mechanical performance under static torsion (ASTM F1717-18)	Mechanical evaluation performed according to ASTM F1717-18 (Endolab 970 200220 30 1413 part 2 rev.0 and 970 200220 30 1414 part 2 rev.0) (assumed to demonstrate acceptable mechanical performance comparable to predicate; no specific quantitative results provided).
Adequate axial tensile force resistance (ASTM F543-17, ASTM F2193-18a)	Mechanical evaluation performed according to ASTM F543-17 and ASTM F2193-18a (Endolab 970.200227.120.868-part1 rev. 0) (assumed to demonstrate acceptable resistance; no specific quantitative results provided).
Adequate torsional force resistance (ASTM F543-17, ASTM F2193-18a)	Mechanical evaluation performed according to ASTM F543-17 and ASTM F2193-18a (Endolab 970.200227.120.867-part2 rev. 0 and 970.200227.120.868part2 rev. 0) (assumed to demonstrate acceptable resistance; no specific quantitative results provided).
Acceptable torsional yield strength, maximum torque, and braking angle (ASTM F543-17 A1)	Mechanical evaluation performed according to ASTM F543-17 - A1 (Endolab 970.200227.120.867-part3 rev. 0 and 970.200227.120.868-part3 rev. 0) (assumed to demonstrate acceptable properties; no specific quantitative results provided).
Acceptable risk of breakage during insertion (ASTM F543-17)	Characterization and evaluation performed according to ASTM F543-17 (Medacta test report ASTM F543 Summary Report) (claimed acceptable risk; no specific methodology or results provided besides the report reference).
Biocompatibility:	Biocompatibility:
Non-pyrogenic (Pyrogenicity Assessment)	Pyrogenicity Assessment Reports for MUST PEDICLE SCREWS IMPLANTS SURGICAL KITS (TF VI-PS-01, RAS-01.008.141 Rev. 5) and MUST LT IMPLANTS (VI-PS-01) (RAS-01.008.277, Rev. 0) were conducted (assumed to demonstrate non-pyrogenicity).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated for each test, but standard ASTM methods often define minimum sample sizes for mechanical testing. For the cadaver surgery, it states "experienced surgeons," implying at least one or more instances.
Data Provenance: Not specified, but given the company is Medacta International SA (Switzerland) and the testing labs are mentioned (Endolab), the data is presumed to be from their internal testing facilities or contracted labs, likely within Europe. No mention of patient data or clinical data is made, so "retrospective or prospective" is not applicable in the context of this submission. This is a bench test and design validation submission.

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. This is not an AI/ML study involving human expert ground truth. The "ground truth" for these tests is defined by engineering standards (e.g., ASTM) and physical measurements. For the cadaver surgery, it states "experienced surgeons" performed the procedure, but their role was to evaluate the instrument's use in a simulated environment, not to establish a "ground truth" for an AI model.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept is for resolving disagreements in expert labeling for AI/ML ground truth, which is not relevant here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical pedicle screw system, not an AI/ML software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is based on:

Engineering Standards: Adherence to established ASTM (American Society for Testing and Materials) standards for spinal implants and medical bone screws to define acceptable mechanical properties.
Physical Measurements/Analysis: Geometrical analysis of threads and characterization of mechanical properties (tensile strength, torsion, etc.).
Risk Analysis: Identification of new risks and verification against predefined acceptance criteria based on this analysis, likely conforming to ISO standards for medical device risk management.
Biocompatibility Testing: Demonstrated through pyrogenicity assessment reports.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no AI/ML device with a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the date January 26, 2021. The text is in a simple, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The text is centered and takes up most of the image.

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Medacta International SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K203482

Trade/Device Name: M.U.S.T. Pedicle Screw Extension and Long Tab Implants Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ, KWP Dated: November 24, 2020 Received: November 27, 2020

Dear Chris Lussier:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K203482

Device Name

M.U.S.T. Pedicle Screw Extension and Long Tab implants

Indications for Use (Describe)

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

Submitter I.

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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: November 24, 2020

II. Device

Device Proprietary Name:	M.U.S.T. Pedicle Screw Extension and Long Tab Implants
Common or Usual Name:	Pedicle screw spinal system
Classification Name:	Thoracolumbosacral Pedicle Screw 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	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device:

M.U.S.T. Pedicle Screw System, K153664, Medacta International SA ●
Reference predicate devices:
M.U.S.T. Pedicle Screw System, K121115, Medacta International SA
M.U.S.T. Pedicle Screw System, K132878, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K141988, Medacta International SA
M.U.S.T. Pedicle Screw System, K162061, Medacta International SA
M.U.S.T. Pedicle Screw System, K171170, Medacta International SA
M.U.S.T. Combined Set Screws, K171758, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K193365, Medacta International SA

IV. Device Description

The M.U.S.T. Extension and M.U.S.T. Long Tab is intended to be used as part of the M.U.S.T. Pedicle Screw system (K121115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) for

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the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system includes cannulated or non-cannulated poly-axial pedicle screws (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K121115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988).

New size of Straight Rods (both Titanium and CoCr version): length 600mm Hex interface at . the end
New size of Straight Rods (Anodized Titanium version): length 600mm ●
Pre-contoured Rods (both Titanium and CoCr version) ●
New sizes of Lateral Connectors: length 80; 100; 125 & 150mm ●
New sizes of Enhanced Cannulated Pedicle Screws: Ø8; Ø9; Ø10 length from 30 to 100mm ●
New cannulated pedicle screws with thread 4 leads (15 and 25 mm) ●
Setscrews in Titanium ●

Intended purpose and the performance specification of the devices are equivalent to the ones of the current US cleared portfolio: screws, rods and lateral connectors are already used in the MUST implant construct.

V. Indications for Use

The M.U.S.T. Pedicle screws system is intended for posterior non-cervical pedicle fixation (T1-S2/ilum) 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

M.U.S.T. Extension .

The new sizes of Straight Rods (Titanium and CoCr version) included in the M.U.S.T. Extension and the predicate devices (K121115) share the following characteristics:

indication for use; ●
design;
diameters;
materials; ●

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biocompatibility; ●
device usage;
sterility;
shelf life;
packaging. ●

The only difference between the Straight Rods included in the M.U.S.T. Extension and the predicate devices (K121115) is the rods length.

M.U.S.T. Extension ●

The new size of Straight Rod and Enhanced Straight Rod (Anodized Titanium version) included in the M.U.S.T. Extension and the predicate devices (K162061) share the following characteristics:

indication for use;
geometry;
diameters; ●
materials; ●
biocompatibility;
device usage;
sterility;
shelf life;
packaging.

The only difference between the Straight Rods included in the M.U.S.T. Extension and the predicate devices (K162061) is the rods length.

M.U.S.T. Extension ●

The subject Pre-contoured Rods and Straight Enhanced Rods (both Titanium and CoCr version) included in the M.U.S.T. Extension and the predicate devices (K141988) share the following characteristics:

indication for use; ●
design; ●
diameters; ●
materials;
biocompatibility; ●
device usage; ●
sterility;
shelf life;
packaging.

The only difference between the Pre-contoured Rods and Straight Enhanced Rods included in the M.U.S.T. Extension and the predicate devices (K141988) is the rods length.

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M.U.S.T. Extension ●

The new sizes of Lateral connectors included in the M.U.S.T. Extension and the predicate devices (K162061) share the following characteristics:

indication for use; ●
geometry;
diameters; ●
materials; ●
interconnection mechanism;
biocompatibility;
device usage;
sterility;
shelf life;
packaging. ●

The only difference between the Lateral connectors included in the M.U.S.T. Extension and the predicate devices (K162061) is the connector length.

M.U.S.T. Extension ●

The new sizes of Enhanced Cannulated Pedicle Screws included in the M.U.S.T. Extension and the predicate devices (K171170 and K141988) share the following characteristics:

indication for use;
design; ●
materials; ●
biocompatibility; ●
device usage;
sterility;
shelf life; ●
packaging. ●

The only difference between the Enhanced Cannulated Pedicle Screws included in the M.U.S.T. Extension and the predicate devices (K141988) is the screws diameters and lengths; the thread of the new sizes is substantially equivalent to the thread shape of the predicate device.

M.U.S.T. Long Tab (LT) ●

The new M.U.S.T. LT Cannulated pedicle screws included in the M.U.S.T. LT and the predicate devices (K153664 and K171170) share the following characteristics:

indication for use;
design; ●
materials;

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diameters;
screw lengths; ●
biocompatibility;
device usage;
sterility; ●
shelf life;
packaging. ●

The only difference between the M.U.S.T. LT Cannulated pedicle screws included in the M.U.S.T. LT and the predicate devices (K153664 and K171170) is the pedicle screw head that has two long tabs, that can easily allow reduction operation during the surgery (two different lengths of reduction; 15mm and 25mm). The MUST LT tulip is equivalent to the predicate device in terms of material and geometry. In fact, the two tabs are intended to the broken, during surgery and after rod reduction. The resulting tulip has a similar profile and dimensions reduced as the predicate device.

The new M.U.S.T. LT Combined setscrew in the M.U.S.T. LT and the predicate devices (K171758) share the following characteristics:

indication for use; ●
diameters; ●
biocompatibility; ●
device usage;
sterility;
shelf life; ●
packaging.

The differences between the M.U.S.T. LT Combined setscrews in the M.U.S.T. LT and the predicate devices (K171758) are material and dimensions.

VII. Performance Data

The addition of the M.U.S.T. Extension and M.U.S.T. LT components to M.U.S.T. - Pedicle Screw System portfolio was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system.

The following validation and tests are being provided in support of the substantial equivalence determination:

Non-Clinical Studies

DESIGN VALIDATION ●

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Geometrical Analysis MUST LT Thread Geometry: To ensure that the implant has o sufficient fixation in the bone, a geometrical analysis was performed in comparison to approved and marketed implants, related to the most important dimensions of the threads.
Cadaver surgery performed according to the well-known MIS percutaneous (Minimally o invasive system) technique (99.PERC46.12 rev.04) by experienced surgeons and according to the M07.138.001 prepared for the Chicago Wetlab.
Tab welding MUST LT Flexion strength test according to IL07.09.598 to characterize the o specific design of the tulip in the dedicated breaking area
PERFORMANCE TESTING ●
- Worst Case definition for ASTM F1717 testing: discussion of implant types and sizes, chosen o as the worst case for mechanical testing of the spinal construct in a vertebrectomy model.
- Mechanical evaluation under static and dynamic axial compression according to ASTM о F1717-18 Standard test methods for Spinal Implants Construct in a Vertebrectomy model: Endolab 970 200220 30 1413 part 1 rev.0 and 970 200220 30 1414 part 1 rev.0
- Mechanical evaluation under static torsion according to ASTM F1717-18 Standard test o methods for Spinal Implants Construct in a Vertebrectomy model: Endolab 970 200220 30 1413 part 2 rev.0 and 970 200220 30 1414 part 2 rev.0
- Mechanical evaluation of axial tensile force resistance according to ASTM F543-17 Standard o specification and test methods for metallic medical bone screws and ASTM F2193-18a Standard Specification and test methods for components used in the surgical fixation of the spinal skeletal and 970.200227.120.868-part1 rev. 0
- Mechanical evaluation of torsion force resistance according to ASTM F543-17 Standard o specification and test methods for metallic medical bone screws and ASTM F2193-18a Standard Specification and test methods for components used in the surgical fixation of the spinal skeletal system: Endolab 970.200227.120.867-part2 rev. 0 and 970.200227.120.868part2 rev. 0
- o Mechanical evaluation of torsional yield strength, maximum torque and braking angle according to ASTM F543-17 Standard specification and test methods for metallic medical bone screws - A1: Endolab 970.200227.120.867-part3 rev. 0 and 970.200227.120.868-part3 rev. O
- Characterization and evaluation of risk of breakage during the insertion in the bone of MUST o screws according to ASTM F543-17 Standard specification and test methods for metallic medical bone screw: Medacta test report ASTM F543 Summary Report

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. PYROGENICITY
- 0 Pyrogenicity Assessment, ENDOTOXINS-MEDIATED PYROGENICITY ASSESSMENT REPORT FOR: "MUST PEDICLE SCREWS IMPLANTS SURGICAL KITS" TF VI-PS-01, RAS-01.008.141 Rev. 5, Dated: 17 October 2020
- 0 Pyrogenicity Assessment, ENDOTOXINS-MEDIATED PYROGENICITY ASSESSMENT REPORT FOR: "MUST LT IMPLANTS (VI-PS-01)", RAS-01.008.277, Rev. 0, Dated: 16 September 2020

Clinical Studies:

No clinical studies were conducted.

VIII. Conclusion

Based on the above information, the M.U.S.T. Extension and M.U.S.T. LT components are substantially equivalent to the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.

Regulation Number and Section

§ 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.