EXPEDIUM SPINE SYSTEM

K130877 · Medos International SARL · NKB · Jun 20, 2013 · Orthopedic

Device Facts

• Record ID: K130877
• Device Name: EXPEDIUM SPINE SYSTEM
• Applicant: Medos International SARL
• Product Code: NKB · Orthopedic
• Decision Date: Jun 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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, 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 metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

The EXPEDIUM Spine System consists of open angled extended, slotted connectors and various rods used for spinal fixation. Connectors are titanium alloy; rods are titanium, stainless steel, or cobalt chrome. The device is used by surgeons in an operating room setting to provide immobilization and stabilization of spinal segments. The system is implanted to treat various spinal pathologies, including deformities and instabilities. The device provides mechanical support to the spine, acting as an adjunct to fusion procedures. It does not involve software, algorithms, or electronic processing.

Clinical Evidence

Bench testing only. Performance data per ASTM F 1798 submitted, including static axial slip and static/dynamic cantilever beam bending tests.

Technological Characteristics

Materials: ASTM F 138 stainless steel, ASTM F 136 titanium alloy, ASTM F 1537 cobalt-chromium-molybdenum alloy. Components: Open angled extended slotted connectors and rods. Mechanical fixation system. No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures (scoliosis/lordosis), tumor, pseudoarthrosis, and failed previous fusion. Also indicated for adolescent idiopathic scoliosis in pediatric patients via posterior non-cervical pedicle screw fixation. Used with autograft/allograft.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EXPEDIUM® Spine System (K041119)
• EXPEDIUM® Spine System (K062174)
• EXPEDIUM® Spine System (K071495)
• EXPEDIUM® Spine System (K073364)
• EXPEDIUM® Spine System (K082942)
• EXPEDIUM® Spine System (K090230)
• EXPEDIUM® Spine System (K101070)
• EXPEDIUM® Spine System (K111136)

Submission Summary (Full Text)

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## 510(K) SUMMARY

# JUN 2 0 2013

A. Submitter Information Manufacturer:

Submitter:

Medos International Sárl Chemin-Blanc 38 2400 Le Locle, Switzerland

DePuy Spine, Inc. . 325 Paramount Drive Raynham, MA 02767

Telephone number: Fax number:

Contact Person:

B. Date Prepared

Email:

C. Device Name

Trade/Proprietary Name:

Common/Usual Name:

Classification Name:

Kirsten Lehmuller 325 Paramount Drive Raynham, MA 02767 508-828-3291 508-828-3797 [e-mail]

March 27, 2013

EXPEDIUM® Spine System

Pedicle screw spinal system

Spinal interlaminar fixation orthosis per 21 CFR §888.3050, KWP Spinal intervertebral body fixation orthosis per 21 CFR §888.3060, KWQ Pedicle screw spinal fixation per 21 CFR §888.3070, MNH, MNI, NKB, OSH

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## Predicate Device Name

Trade name: EXPEDIUM® Spine System (K041119) EXPEDIUM® Spine System (K062174) EXPEDIUM® Spine System (K071495) EXPEDIUM® Spine System (K073364) EXPEDIUM® Spine System (K082942) EXPEDIUM® Spine System (K090230) EXPEDIUM® Spine System (K101070) EXPEDIUM® Spine System (K111136)

#### Device Description E.

The subject additions to the EXPEDIUM 4.5mm, 5.5mm, and 6.35mm Spine Systems consist of open angled extended, slotted connectors and various rods. The connectors are available in titanium alloy with lengths of 5, 10, 15, and 20mm. The rods vary in size and geometries to accommodate patient anatomy and are available in materials of titanium, stainless steel, and cobalt chrome.

#### Intended Use F.

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, 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 metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

D.

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

The proposed modifications to the EXPEDIUM open extended, angled slotted connector is similar to the predicate (K101070) except the head/rod interconnection is open rather than closed, like the predicate monoaxial screw (K062174). The proposed EXPEDIUM rods are similar to the predicates (K041119, K062174, K071495, K082942, K090230, and K101070) except for the varying lengths and slight modifications to the geometry.

#### G. Materials

Manufactured from ASTM F 138 implant grade stainless steel, ASTM F 136 implant grade titanium alloy, and ASTM F 1537 implant grade cobalt -chromiummolybdenum alloy.

#### H. Performance Data

Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM Spine System connector addressed in this notification. This testing was compromised of static axial slip and both static and dynamic cantilever beam bending. A rationale is provided in place for performance testing for the subject rods of this submission.

#### l. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the subject devices are as safe, as effective, and perform as well as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and tail. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public I lealth Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

June 20, 2013

Medos International, Sárl % DePuy Spine, Incorporated Ms. Kirsten Lehmuller 325 Paramount Drive Raynham, Massachusetts 02767

Re: K130877

Trade/Device Name: EXPEDIUM® Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Codes: NKB, OSH, MNH. MNH, MNI, KWP, K WQ Dated: April 4, 2013 Received: April 5, 2013

Dear Ms. Lehmuller:

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 enacunent date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither class 11 (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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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## Page 2 - Ms. Kirsten Lehmuller

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Officc of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Erin Keith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130877

Device Name: EXPEDIUM® Spine System

Indications For Use:

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, and/or fordosis); 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 metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Prescription Use X

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130877

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