The EXPEDIUM Verse System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Verse System is intended for noncervical pedicle fixation for 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.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Verse System is intended for noncervical pedicle fixation and nonpedicle fixation for 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.

When used for posterior non-cervical pediativ patients, the EXPEDIUM Verse System metallic implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The EXPEDIUM Verse system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM® System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with CONFIDENCE High Viscosity Spinal Cement, the EXPEDIUM VERSE Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The EXPEDIUM Fenestrated Screw System augmented with the CONFIDENCE High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

Device Description

The EXPEDIUM fenestrated screws are polyaxial pedicle screws designed with a cannulation that runs the length of the screw shank and lateral fenestrations. The fenestrated screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The EXPEDIUM VERSE® fenestrated screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and cobalt chromium alloy (Co-28Cr-6Mo) conforming to ASTM F1537. The fenestrated screws are intended for use with components of the EXPEDIUM System such as rods and set screws to create an implant system to meet the patient's physiological and anatomical requirements. The EXPEDIUM VERSE® fenestrated screws are intended for use with components of the EXPEDIUM Spine System, including VERSE, to create an implant system to meet the patient's physiological and anatomical requirements.

The fenestrated screws may be used in conjunction with CONFIDENCE High Viscosity Spinal Cement a self-curing polymethylmethacrylate (PMMA) radiopaque bone cement. The CONFIDENCE Spinal Cement System® kits include the cement and accessories necessary to mix, prepare and deliver the cement. The fenestrated screw cannula connects the CONFIDENCE spinal cement delivery system to the fenestrated screw. An alignment guide facilitates orientation of the fenestrated screw to accept the fenestrated screw cannula for cement delivery. Please refer to the surgical technique manual.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the EXPEDIUM VERSE® Fenestrated Screw System. It focuses on the device's substantial equivalence to a predicate device, primarily addressing a labeling change for reprocessing of sterile fenestrated screws.

Critically, this document explicitly states: "No additional testing was conducted to support this submission."

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as no such study or associated data is detailed in this document. The FDA clearance for this particular submission (K220374) was based on the device's substantial equivalence to an existing predicate device, not on new performance testing to prove specific acceptance criteria for AI or other advanced functionalities.

The queries in your prompt (e.g., sample size for test/training sets, expert consensus for ground truth, MRMC study, standalone algorithm performance) are highly relevant for the evaluation of AI/ML-driven medical devices, but they are not applicable to the information contained in this 510(k) summary, which concerns a physical medical device (spinal screws) and a labeling update.

Summary

{0}------------------------------------------------

March 8, 2022

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.

Medos International SARL Megan Smith Regulatory Affairs Specialist Depuy Synthes Spine 325 Paramount Dr Raynham, Massachusetts 02767

Re: K220374

Trade/Device Name: EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ, KWP Dated: February 7, 2022 Received: February 9, 2022

Dear Megan Smith:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 (OS) 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 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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220374

Device Name

EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(K) SUMMARY

	Submitter Information
	Manufacturer:	Medos International SARLChemin-Blanc 382400 Le Locle, Switzerland
	Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
	Contact Person:Telephone:Email:	Megan Smith978-538-8797msmith94@its.jnj.com
B.	Date Prepared	February 7, 2022
C.	Device Name
	Trade/Proprietary Name:	EXPEDIUM VERSE® Fenestrated ScrewSystem (Sterile Fenestrated Screws)
	Common/Usual Name:	Thoracolumbosacral Pedicle Screw System
	Regulatory Class:	21 CRF 888.3070, 888.3060, 888.3050
	Product Codes:	NKB, KWQ, KWP

Predicate Device Names D.

EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System -Predicate: K200245

Device Description Summary

{5}------------------------------------------------

Indications for Use

The EXPEDIUM Verse System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic. lumbar and sacral spine.

The EXPEDIUM Verse System is intended for noncervical pedicle fixation and nonpedicle fixation for 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.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM Verse System is intended for noncervical pedicle fixation and nonpedicle fixation for 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.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Verse System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Verse system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used for posterior non-cervical pedicle screw fixation in pediatric patients. the EXPEDIUM® System is indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by turnor and/or trauma, pseudarthrosis, and/or failed previous fusion. The EXPEDIUM® System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach

{6}------------------------------------------------

involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The EXPEDIUM Fenestrated Screw System augmented with the CONFIDENCE High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

Indications for Use Comparison

The indications for use are comparable between the subject and predicate devices

Technological Comparison

The only change is a labeling change to allow for reprocessing of the sterile fenestrated screws once they are removed from sterile packaging and rendered non-sterile but prior to use. The screws remain single use implants identical to the predicate. There is no change to the design of the screws including the schematics, material, principle of operation, packaging, biocompatibility, or MR compatibility from the predicate device. When in sterile packaging, the subject devices are identical to the sterile versions of the predicate. Once removed from sterile packaging but prior to use, the subject devices are identical to the non-sterile versions of the predicate and follow the same cleaning and reprocessing instructions contained in the instructions for use as the predicate non-sterile devices.

Non-Clinical and/or Clinical Tests Summarv

No additional testing was conducted to support this submission.

Conclusion

Based on engineering analyses, the subject device with the proposed labeling update regarding "opened-but-unused" language is substantially equivalent to the predicate device. The indications for use, technological characteristics, and performance are comparable. Therefore, the proposed modifications raise no new questions of safety or effectiveness.

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.