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

The EXPEDIUM® Spine 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 for posterior non-cervical pediatic patients, the EXPEDIUM® System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scolosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® System is intended to treat pediatric patients diagnosed with: 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.

The EXPEDIUM VERSE® System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformites 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 for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); 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 progressive spinal deformities (1.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis. Additionally, the EXPEDIUM VERSE® 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 VERSE® system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine Systems consists of metallic implants intended to provide immobilization and stabilization of spinal segments. The EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine Systems also consists of longitudinal rods, monoaxial screws, polyaxial screws, uniplanar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers.

AI/ML Overview

This document is a 510(k) summary for the EXPEDIUM® Spine System and EXPEDIUM VERSE® Spine System, primarily focused on obtaining clearance for modified Indications for Use to broaden indications in the pediatric population. It does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.

The document discusses the device description, indications for use, similarities and differences with predicate devices, and materials. Under "J. Performance Data," it explicitly states:

"Additional performance data is not provided since this submission seeks a broadening of pediatric indications only."

Therefore, I cannot extract the requested information from the provided text. The document indicates that no new performance data or studies were conducted or provided for this submission regarding performance against acceptance criteria.

Summary

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April 24, 2020

Medos International Sàrl % Rhoda Maddonni Regulatory Scientist, Global Regulatory Affairs DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767

Re: K200245

Trade/Device Name: EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: January 30, 2020 Received: January 31, 2020

Dear Rhoda Maddonni:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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, MBE Acting 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) K200245

Device Name EXPEDIUM® Spine System

Indications for Use (Describe)

The EXPEDIUM® Spine 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 of the thoracic, lumbar and sacral spine.

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.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.

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Indications for Use

510(k) Number (if known) K200245

Device Name EXPEDIUM VERSE® Spine System

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)
-----------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

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."

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510(K) SUMMARY : EXPEDIUM® Spine System and EXPEDIUM VERSE® Spine System

A.	Submitter Information
	Manufacturer:	Medos International SARLChemin-Blanc 382400 Le Locle, Switzerland
	Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
	Contact Person:	Rhoda Maddonni
	Telephone:Fax:Email:	(215) 793-7022(215) 540-4730rmaddonn@its.jnj.com
B.	Date Prepared		April 24, 2020
C.	Device Name
	Trade/Proprietary Name:	EXPEDIUM® Spine SystemEXPEDIUM VERSE® Spine System
	Common/Usual Name:	Pedicle screw spinal system
	Regulatory Class:	Class II
	Classification Names:	NKB - 21 CFR §888.3070Thoracolumbosacral pedicle screw system
	Additional Product Codes:	KWP, KWQ
	Review Panel:	Orthopedic
D.	Predicate Devices Name
	Primary Predicate:	CD HORIZON® Spinal System (K162494)
	Additional Predicates:	Xia® 3 and Xia® 4.5 Spinal Systems (K142381)EXPEDIUM® Spine System (K160904)EXPEDIUM VERSE® Spine System (K142185)

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E. Submission Purpose

Obtain clearance for a modified Indications for Use to broaden indications in the pediatric population for the subject devices, the EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine System.

F. Device Description

G. Indications for Use

The EXPEDIUM® Spine System

The EXPEDIUM® Spine 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® Spine 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® System is indicated as an adjunct to fusion 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 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.

The EXPEDIUM VERSE® Spine System

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.

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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 progressive spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM VERSE® 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 VERSE® system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

H. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use

The intended use, technological characteristics, and performance of the EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine System are consistent with those of the predicate devices for the expanded pediatric indication as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine System are intended to treat pediatric patients diagnosed with: spondylolisthesis / spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion.

I. Materials

The EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine System components are available in commercially pure titanium or titanium alloy conforming to ASTM F67, ASTM F136 or ASTM F1472 specifications; stainless steel conforming to ASTM F138, ASTM F1314, or F2229 specifications; cobalt-nickel-chromium

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molybdenum alloy wire conforming to ASTM F562 specifications; as well as longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F1537 specifications.

J. Performance Data

Evaluation of the subject devices' intended use, technological characteristics, device performance and system components were performed. Additional performance data is not provided since this submission seeks a broadening of pediatric indications only.

K. Conclusion

The expanded pediatric indications of the EXPEDIUM® Spine System and the EXPEDIUM VERSE® Spine System (subject devices) are identical to the cleared pediatric indications of the predicates CD HORIZON® Spinal System and Xia® 3 and Xia® 4.5 Spinal Systems. The evaluation of the subject devices' intended use, technological characteristics, and system components demonstrates substantial equivalence with 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.