The M.U.S.T. Pedicle screw 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 subject M.U.S.T. Pedicle Screw System - Extension is a Medacta M.U.S.T. Pedicle Screws System line extension aiming to include the following new implants:

M.U.S.T. Uniplanar screws (solid and cannulated);
M.U.S.T. Uniplanar reduction screws (solid and cannulated);
M.U.S.T. polvaxial pedicle screws (solid and cannulated);
M.U.S.T. polyaxial reduction pedicle screws (solid and cannulated);
M.U.S.T. S2AI polyaxial cannulated screws (with or without HA plasma spray coating, fully and partially threaded);
M.U.S.T. S2AI polyaxial reduction cannulated screws (with or without HA plasma spray coating, fully and partially threaded);
M.U.S.T. rod straight, transition and pre-contoured (double curvature, J-rod and Z-rod) of different lengths and Ø5.5 or Ø6.0 mm diameters made of Ti6A14V or CoCrMo alloys;
M.U.S.T. Link cross connectors for Ø5.5 or Ø6.0 mm rods.
The M.U.S.T. Pedicle Screw System - Extension implants are provided individually packed, sterile and single-use.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (M.U.S.T. Pedicle Screw System - Extension) and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving clinical efficacy or diagnostic accuracy with extensive studies. Therefore, the information provided does not contain the typical details you would find for an AI/software as a medical device (SaMD) study that includes acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader studies.

The provided document describes an extension to an existing pedicle screw system, which primarily involves new implant designs and sizes. The performance data section focuses on non-clinical studies related to mechanical testing and biocompatibility, as is typical for implantable orthopedic devices.

Below is an analysis based on the information available, noting where specific details (like those related to AI/software performance) are not applicable or not provided in this type of submission.

Acceptance Criteria and Study for M.U.S.T. Pedicle Screw System - Extension

Given that this is a 510(k) for an extension to an orthopedic implant system and not an AI/SaMD, the "acceptance criteria" and "device performance" are primarily related to mechanical integrity and biological safety, rather than diagnostic performance metrics. The "study" refers to the non-clinical tests performed to demonstrate these aspects.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (Summary from Non-Clinical Studies)
Design Validation	- M.U.S.T. Uniplanar & Polyaxial Screws, Rods, and Cross Connectors: Design validated to ensure compatibility with existing and new implants and instruments. - M.U.S.T. S2AI: Design validated for new features.
Mechanical Performance (Worst-Case Determination - ASTM F1798-21)	- M.U.S.T. Link cross connector for Ø5.5 and Ø6 rods: Worst-case determined and tested. (Implicitly, the performance met the specified standard for interconnections, supporting substantial equivalence). - Interconnection mechanism: Worst-case determined and tested. (Implicitly, performance met standard).
Mechanical Performance (Static and Dynamic Compression Bending - ASTM F1717-21)	- Pedicle screw constructs: Tested for static and dynamic compression bending. (Implicitly, the performance met the specified standard for pedicle screw internal spinal fixation systems, supporting substantial equivalence).
Mechanical Performance (Static Torsion - ASTM F1717-21)	- Pedicle screw constructs: Tested for static torsion. (Implicitly, the performance met the specified standard, supporting substantial equivalence).
Mechanical Performance (Tulip Opening)	- Forces causing tulip opening during final tightening: Evaluated. (Implicitly, demonstrated that the forces are within acceptable limits for safe use).
Biocompatibility	- Assessment conducted: (Implicitly, the device components are biocompatible according to established standards, including the M.U.S.T. SI Screw coating validation for S2AI screws).
Pyrogenicity (Bacterial Endotoxin Test - EP §2.6.14 / USP <85>)	- Tests conducted: Bacterial endotoxin test (LAL test) performed. (Implicitly, results demonstrated acceptable endotoxin levels).
Pyrogenicity (Pyrogen Test - USP <151>)	- Tests conducted: Pyrogen test performed for pyrogenicity determination. (Implicitly, results demonstrated acceptable pyrogen levels). (Note: The devices are not labeled as non-pyrogenic or pyrogen-free.)
Shelf-Life	- Evaluation conducted: (Implicitly, the device's shelf-life was determined and validated to ensure product stability and performance over time.)

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of this 510(k) submission. The "test set" for this type of device refers to manufactured devices or components subjected to standardized mechanical and biological tests. There are no "patients" or "data provenance" in the sense of clinical study data for these non-clinical tests. The tests are typically performed on a statistically relevant number of samples of the device components/constructs to demonstrate compliance with standards. The specific sample sizes for each mechanical and biological test are not detailed in this summary but would be specified in the full test reports.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. "Ground truth" established by experts is relevant for diagnostic devices or AI/SaMD where clinical judgment is the benchmark. For a pedicle screw system, compliance with engineering standards (e.g., ASTM) and biocompatibility requirements are the "ground truth" for non-clinical testing. This involves engineering and scientific experts familiar with these standards, but not clinical "radiologists" establishing diagnostic ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical studies, especially for evaluating subjective diagnoses. Mechanical and biological test results are typically objective measurements against predefined thresholds, not requiring expert adjudication in this manner.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is specific to diagnostic imaging devices or AI/SaMD that assist human readers. It is not relevant for an orthopedic implant like a pedicle screw system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This device is a physical implant, not a software algorithm.

7. Type of Ground Truth Used

For this device, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness relies on:

Engineering Standards: Compliance with established ASTM (American Society for Testing and Materials) standards for spinal implants (e.g., ASTM F1798-21, ASTM F1717-21) for mechanical performance.
Biological Standards: Compliance with relevant standards for biocompatibility (ISO 10993 series) and pyrogenicity (European Pharmacopoeia, USP).
Predicate Device Performance: The primary ground truth is the demonstration that the new components perform equivalently to or better than previously cleared predicate devices, meeting established safety and performance benchmarks.

8. Sample Size for the Training Set

Not applicable. There is no software algorithm or AI model being "trained" for this physical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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February 13, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta USA 6386 Global Drive, Suite 101 Memphis, Tennessee 38141

Re: K234048

Trade/Device Name: M.U.S.T. Pedicle Screw System - Extension Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: December 21, 2023 Received: December 21, 2023

Dear Christopher 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.02.13
10:13:36 -05'00'

for 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) K234048

Device Name

M.U.S.T. Pedicle Screw System - Extension

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

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 and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: December 21, 2023 Date Revised: February 02, 2024

II. Device

Device Proprietary Name:	M.U.S.T. Pedicle Screw System - Extension
Common or Usual Name:	Thoracolumbosacral Pedicle Screw System
Classification Name:	Thoracolumbosacral Pedicle Screw System
Primary Product Code	NKB
Secondary Product Code	KWP, KWQ
Regulation Number:	21 CFR 888.3070, 21 CFR 888.3050, 21 CFR 888.3060
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following predicate devices.

Primary Predicate device:

M.U.S.T. Pedicle Screw Extension, K203482, Medacta International SA ●
Additional Predicate devices
Apex-DL Spine System, K143683, SpineCraft LLC ●
Whistler Modular Pedicle Screw System, K182478, Evolution Spine LLC ●
M.U.S.T. Pedicle Screw System, K171170, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K162061, Medacta International SA
M.U.S.T. Pedicle Screw System, K141988, Medacta International SA
M.U.S.T. Pedicle Screw System, K132878, Medacta International SA
M.U.S.T. Pedicle Screw System, K121115, Medacta International SA
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System, K171595, Medacta International SA

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IV. Device Description

The subject M.U.S.T. Pedicle Screw System - Extension is a Medacta M.U.S.T. Pedicle Screws System line extension aiming to include the following new implants:

M.U.S.T. Uniplanar screws (solid and cannulated);
M.U.S.T. Uniplanar reduction screws (solid and cannulated);
M.U.S.T. polvaxial pedicle screws (solid and cannulated); ●
M.U.S.T. polyaxial reduction pedicle screws (solid and cannulated); ●
M.U.S.T. S2AI polyaxial cannulated screws (with or without HA plasma spray coating, fully and partially threaded);
M.U.S.T. S2AI polyaxial reduction cannulated screws (with or without HA plasma spray coating, ● fully and partially threaded);
M.U.S.T. rod straight, transition and pre-contoured (double curvature, J-rod and Z-rod) of different lengths and Ø5.5 or Ø6.0 mm diameters made of Ti6A14V or CoCrMo alloys;
M.U.S.T. Link cross connectors for Ø5.5 or Ø6.0 mm rods. ●

The M.U.S.T. Pedicle Screw System - Extension implants are provided individually packed, sterile and single-use.

V. Indications for Use

The M.U.S.T. Pedicle screw 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.

Comparison of Technological Characteristics VI.

The subject M.U.S.T. Pedicle Screw System - Extension and the predicate devices (Medacta devices -K12115, K132878, K141988, K162061, K171170, K203482, in addition to Apex-DL Spine System -K143683 for M.U.S.T. uniplanar and polyaxial screws and Whistler Modular Pedicle Screw System -K182478 for M.U.S.T. S2AI screws) are substantially equivalent with respect to the following characteristics:

Design, except for S2AI partial thread and J-rod/Z-rod; ●
Rods compatibility: ●
Materials; ●
Coating, if available; ●
Biocompatibility:
Device usage;
Packaging;
Shelf-life; and ●
Sterilization.

The subject M.U.S.T. Pedicle Screw System - Extension differ from the predicate devices (Medacta devices - K121115, K132878, K162061, K171170, K203482, in addition to Apex-DL Spine System - K143683 for M.U.S.T. uniplanar and polyaxial screws and Whistler Modular Pedicle Screw System - K182478 for M.U.S.T. S2AI screws) with respect to:

Range of products; .

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. Thread of S2AI screws: and
J-rod and Z-rod design. .

Discussion

The partially different range of products between the subject and predicate devices has no impact on safety and effectiveness:

M.U.S.T. uniplanar, polyaxial and S2AI screws range of sizes is included within the one of the . predicate devices.
. The new Ø6mm rods do not introduce any new worst case with respect to the predicate devices (rods Ø5.5mm cleared within K121115, K162061, K203482) due to the larger diameter.
The subject M.U.S.T. Link cross connector for Ø6mm rods also, do not introduce any new worst ● case with respect to the predicate devices (K132878) as demonstrated by comparative testing.

The availability of the partial thread for the subject M.U.S.T. S2AI screws does not raise any new issue related to safety and effectiveness since the core diameter of the subject screw is larger respect to the one of the predicate devices (K141988, K203482 and K182478) with a full thread version.

The subject J-rod and Z-rod do not introduce any new issue with regards to safety and effectiveness since they can be considered as pre-contoured rods with slightly modified curvature.

The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject devices respect to the predicate devices.

VII. Performance Data

Based on the risk analysis, testing activities were conducted to written protocols. The following validations and tests are provided in support of the substantial equivalence determination:

Non-Clinical Studies

o DESIGN VALIDATION

M.U.S.T. Uniplanar & Polyaxial Screws for Ø5.5 and 6.0 rods, Ø5.5 and 6.0 rods and cross . connectors - Pedicle Screw System Design validate the subject devices features ensuring compatibility with existing and new implants and instruments
M.U.S.T. S2AI - Pedicle Screw System design validation to validate the new features
o PERFORMANCE TESTING
- Worst-case determination between M.U.S.T. Link cross connector for Ø5.5 and Ø6 rods . according to ASTM F1798-21
- Worst-case determination mechanical test of interconnection mechanism according to ASTM . F1798-21
- Static and dynamic compression bending test on pedicle screw constructs according to ASTM F1717-21
- Static torsion test on pedicle screw constructs according to ASTM F1717-21 ●
- Evaluation of the forces causing tulip opening during the final tightening process

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. Justification to use M.U.S.T. SI Screw coating validation activity to characterize M.U.S.T. S2AI screw
PYROGENICITY O
- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is . equivalent to USP chapter <85>)
- Pyrogen test according to USP chapter <151> for pyrogenicity determination .
- The subject devices are not labeled as non-pyrogenic or pyrogen free. .

BIOCOMPATIBILITY assessment O

SHELF-LIFE evaluation о

Clinical Studies:

No clinical studies were conducted. ●

VIII. Conclusion

The information provided above supports that the subject devices are substantially equivalent to the predicate devices.

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.