ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS

K141509 · Medos Sarl · PGM · Aug 22, 2014 · Orthopedic

Device Facts

• Record ID: K141509
• Device Name: ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
• Applicant: Medos Sarl
• Product Code: PGM · Orthopedic
• Decision Date: Aug 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ISOLA Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The ISOLA Growing Spine System may be used with any cleared traditional ISOLA Spine System 3/16 inch rod constructs. The EXPEDIUM Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM Growing Spine System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM Spine Systems. The EXPEDIUM Growing Spine System is not intended to be used with 4.0mm diameter screws.

Device Story

Growing rod system consisting of connectors designed to convert traditional fusion constructs into non-fusion growth-enabling constructs; allows periodic surgical lengthening as patient grows. Components interact with rods (4.5-5.5mm or 3/16 inch), hooks, screws, offset connectors, and cross connectors. Used in surgical setting by physicians to treat pediatric spinal deformities. System provides mechanical stabilization while permitting spinal growth; intended to maintain deformity correction over time.

Clinical Evidence

Bench testing only. Performance characterized via static and dynamic compression bending and static torsion testing per ASTM F1717.

Technological Characteristics

Components manufactured from ASTM F-138 stainless steel and ASTM F-136 titanium alloy. System includes connectors, rods, hooks, screws, offset connectors, and cross connectors. Mechanical stabilization principle. No software or electronic components.

Indications for Use

Indicated for patients <10 years old with potential for spinal growth requiring surgical correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis.

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

• Medtronic CD Horizon® Growth Rod Conversion Set (K133904)
• EXPEDIUM Spine System (K111136)
• ISOLA Spine System (K980485)
• Harrington Spinal Rod System (Pre-Amendment)

Reference Devices

• ISOLA Spine System (K922504)

Submission Summary (Full Text)

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July 29, 2022

Medos International Sárl c/o Kirsten Lehmuller DePuy Spine, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K141509

Trade/Device Name: ISOLA® and EXPEDIUM® Growing Spine Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGM

Dear Kirsten Lehmuller:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 22, 2014. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, [phone], [e-mail]

Sincerely,

Ronald P. Jean -S

Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

August 22, 2014

Medos International Sárl % Ms. Kirsten Lehmuller DePuy Spine, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767

Re: K141509

Trade/Device Name: ISOLA® and EXPEDIUM® Growing Spine Systems Regulatory Class: Unclassified Product Code: PGM Dated: June 5, 2014 Received: June 10, 2014

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 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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

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

Sincerely yours.

# Ronald刷Nean -S 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

510(k) Number (if known) K141509

Device Name

ISOLA® and EXPEDIUM® Growing Spine Systems

### Indications for Use (Describe)

The ISOLA® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The ISOLA® Growing Spine System may be used with any cleared traditional ISOLA® Spine System 3/16 inch rod constructs.

The EXPEDIUM® Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM® Growing System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM® Spine Systems. The EXPEDIUM® Growing Spine System is not intended to be used with 4.0mm diameter screws.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) SUMMARY

B.

C.

#### A. Submitter Information

| | Medos International Sárl<br>Chemin-Blanc 38<br>2400 Le Locle, Switzerland |
|-------------------------|---------------------------------------------------------------------------|
| Contact Person: | Kirsten Lehmuller |
| Address: | 325 Paramount Drive |
| | Raynham, MA 02767 |
| Telephone number: | 508-828-3291 |
| Fax number: | 508-828-3797 |
| Email: | [e-mail] |
| Date Prepared | June 5, 2014 |
| Device Name | |
| Trade/Proprietary Name: | ISOLA® and EXPEDIUM® Growing Spine Systems |
| Common/Usual Name: | Growing Rod System |
| Classification Name: | Unclassified |
| Product Code: | PGM |

#### D. Predicate Device Name

| Trade name: | Medtronic CD Horizon® Growth Rod Conversion Set |
|-------------|-------------------------------------------------|
| | (K133904) |
| | EXPEDIUM Spine System (K111136) |
| | ISOLA Spine System (K980485) |
| | Harrington Spinal Rod System (Pre-Amendment) |

#### E. Device Description

The ISOLA and EXPEDIUM Growing Spine Systems consist of an assortment of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct that can be surgically lengthened on a periodic basis as the patient

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grows. The ISOLA and EXPEDIUM Growing Spine Systems' components are manufactured from titanium alloy and stainless steel and are designed to interact with constructs consisting of rods ranging in diameter from 4.5 to 5.5mm, hooks, screws, offset connectors, and cross connectors. The ISOLA and EXPEDIUM Growing Spine Systems are intended for use only with ISOLA (3/16 inch rod diameter) and EXPEDIUM Spinal Systems (4.5 and 5.5mm rod diameter) fusion constructs for cleared pediatric use.

#### F. Intended Use

The ISOLA Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The ISOLA Growing Spine System may be used with any cleared traditional ISOLA Spine System 3/16 inch rod constructs.

The EXPEDIUM Growing Spine System is indicated for patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The EXPEDIUM Growing Spine System may be used with any cleared traditional 4.5 and 5.5 EXPEDIUM Spine Systems. The EXPEDIUM Growing Spine System is not intended to be used with 4.0mm diameter screws.

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

The subject ISOLA and EXPEDIUM Growing Spine Systems have the same fundamental technology and intended use as the predicate Harrington Spinal Rod System (preamendment) and CD HORIZON® Growth Rod Conversion Set (K133904, SE 02/25/2014) for the treatments of spinal deformities in a non-fusion manner. Additionally, the subject extended tandem connectors are substantially equivalent to tandem connectors previously cleared in the ISOLA Spine System (K922504, K980485). The subject devices are similar in materials, manufacturing, and sterilization as the previously cleared ISOLA and EXPEDIUM Spine Systems.

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#### G. Materials

The ISOLA and EXPEDIUM Growing Spine Systems are manufactured from ASTM F-138 implant grade stainless steel and ASTM F-136 implant grade titanium alloy.

#### H. Performance Data

Performance data per ASTM F 1717 (static and dynamic compression bending and static torsion) were submitted to characterize the subject ISOLA and EXPEDIUM Growing Spine Systems components addressed in this notification.

#### l. Conclusion

Both the Performance Testing and Substantial Equivalence Justification demonstrate that the proposed device is substantially equivalent to the predicate devices.