PASS LP Spinal System

K142798 · Medicrea International SA · MNH · Mar 25, 2015 · Orthopedic

Device Facts

• Record ID: K142798
• Device Name: PASS LP Spinal System
• Applicant: Medicrea International SA
• Product Code: MNH · Orthopedic
• Decision Date: Mar 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PASS LP Spinal System includes a pedicle system intended to provide immobilization 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 thoracic, lumbar, and sacral spine: Fractures Dislocation Failed previous fusion (Pseudoarthrosis) Spinal stenosis Degenerative spondylolisthesis with objective evidence of neurological impairment Spinal deformations such as scoliosis or kyphosis. Loss of stability due to tumors. The PASS LP Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having, implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion. The PASS LP also includes hooks and sacral/iliac screws indicated for degenerative disc disease (ddd) 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion. Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Story

PASS LP Spinal System is a pedicle screw-based spinal fixation system used for surgical stabilization of thoracic, lumbar, and sacral spine. System components include pedicle screws, hooks, sacral/iliac screws, rods, clamps, nuts, and crosslinks. Surgeons use these components to create rigid, patient-specific constructs to immobilize spinal segments during fusion procedures. The device is used in an operating room setting by orthopedic or neurosurgeons. By providing mechanical stability, the system facilitates bone fusion, potentially correcting spinal deformities and alleviating pain associated with instability or degenerative conditions. The system is designed for use with autograft or allograft bone material.

Clinical Evidence

No clinical studies were performed. Bench testing only, including biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen testing) and mechanical testing (dynamic axial compression per ASTM F1717).

Technological Characteristics

Implantable spinal fixation system. Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136/ISO 5832-3 and Cobalt-chromium molybdenum alloy per ISO 5832-12/ASTM F1537. Components: Monoaxial/polyaxial pedicle screws, hooks, rods, sacral/iliac screws, clamps, nuts, crosslinks. Mechanical principle: Rigid fixation via construct assembly. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for skeletally mature patients and pediatric patients (adolescent idiopathic scoliosis) requiring spinal immobilization/stabilization as an adjunct to fusion. Treats acute/chronic instabilities or deformities of thoracic, lumbar, and sacral spine including fractures, dislocations, pseudoarthrosis, spinal stenosis, degenerative spondylolisthesis, scoliosis, kyphosis, lordosis, and tumors. Severe spondylolisthesis (Grades 3-4) at L5-S1 indicated for skeletally mature patients only. Pediatric use limited to posterior approach.

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

• PASS LP Spinal System (K123138)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

March 25, 2015

Medicrea International S.A. Ms. Audrev Vion Regulatory Affairs Manager 14 Porte Du Grand Lyon 01700 Neyron France

Re: K142798

Trade/Device Name: PASS LP Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, KWP, MNI, OSH Dated: March 5, 2015 Received: March 9, 2015

Dear Ms. Vion:

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, 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 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. Audrey Vion

forth in the quality systems (OS) 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 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" (21CFR 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 vours.

# Lori A. Wiggins -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) k142798

Device Name

PASS LP Spinal System

#### Indications for Use (Describe)

The PASS LP Spinal System includes a pedicle system intended to provide immobilization 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 thoracic, lumbar, and sacral spine: Fractures Dislocation Failed previous fusion (Pseudoarthrosis) Spinal stenosis Degenerative spondylolisthesis with objective evidence of neurological impairment Spinal deformations such as scoliosis or kyphosis. Loss of stability due to tumors.

The PASS LP Spinal Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis

(Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having, implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks and sacral/iliac screws indicated for degenerative disc disease (ddd) 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, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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)

FORM FDA 3881 (1/14)

Page 1 of 2

PSC Publishing Sarvices [phone] ESF

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FORM FDA 3881 (1/14)

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#### 510(K) SUMMARY l.

1. DEVICE SUBMITTER MEDICREA® INTERNATIONAL S.A. 14 Porte Du Grand Lyon 01700 NEYRON- France

Phone: [phone] Fax: [phone]

Contact Person: Audrey VION Regulatory Affairs Manager [e-mail]

Date Prepared: 03/05/2015

#### 2. DEVICE

Name of Device: PASS LP Spinal System

Common or Usual Name: Spinal Lumbar Fixation System

Classification Name:

- > orthosis, spinal pedicle fixation per MNI 888.3070
- > orthosis, spondylolisthesis spinal fixation per MNH 888.3070
- V appliance, fixation, spinal interlaminal per KWP 888.3050
- v pedicle screw spinal system, Adolescent Idiopathic Scoliosis per OSH 888.3070

Regulatory Class: II

Product Code: MNI, MNH, KWP and OSH

### 3. PREDICATE DEVICE

PASS LP Spinal System, K123138.

This predicate has not been subject to a design-related recall. No reference device was used in this submission.

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## 4. DEVICE DESCRIPTION

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobaltchromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP Spinal System, with the addition of new components: "Monoaxial Pedicle Screws' and 'Rod Connectors'.

#### 5. INDICATIONS FOR USE

The PASS LP Spinal Systems include a pedicle system 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 thoracic, lumbar, and sacral spine:

- · Fractures
- · Dislocation
- . Failed previous fusion (Pseudoarthrosis)
- . Spinal stenosis
- . Degenerative spondylolisthesis with objective evidence of neurological impairment
- . Spinal deformations such as scoliosis or kyphosis.
- Loss of stability due to tumors. .

The PASS LP Spinal System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also includes hooks and rods and sacral/iliac screws indicated for degenerative disc disease (ddd) 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, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allograft and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Indications For Use statement for the PASS LP Spinal System is identical to the predicate device. Both the subject and predicate device have the same intended use for the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine.

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### 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the features and characteristics of the PASS LP Spinal System to its predicate device.

| Device | PASS LP Spinal System -<br>New Components | PASS LP Spinal System |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | NA | K123138 |
| Intended use | | |
| Thoracic, Lumbar<br>spine | Yes | Yes |
| Posterior<br>Approach | Yes | Yes |
| Design | | |
| Rod Connectors | | |
| Rod diameters | Ø5.5 or Ø6mm | Ø5.5 or Ø6mm |
| Bone anchorage<br>connection | Polyaxial | Polyaxial |
| Connector<br>Angulation | 45° in the frontal plane | 50° in the frontal plane |
| Color Coded | Yes | Yes |
| Shape | Rod<br>part<br>pre-bent ( radius<br>135.50mm) | Pre-bent rod (radius 135.50mm) |
| Monoaxial Pedicle Screws | | |
| Screw Diameters | Ø4.5mm to Ø7.5mm | Ø4.5mm to Ø7.5mm |
| Screw Lengths | From 25mm to 60mm with 5mm<br>increment | From 25mm to 60mm<br>with<br>5mm<br>increment |
| Color Coded | Yes | Yes |
| Shape | Conical thread<br>Spherical head for connection<br>with<br>other<br>PASS<br>LP<br>components<br>Breakable threaded part for Nut<br>tightening | Conical thread<br>Spherical head for connection with<br>other PASS LP components<br>Breakable threaded part for Nut<br>tightening |
| Threaded<br>Extension | Long<br>threaded<br>short<br>or<br>extension | Long threaded extension |
| Materials | | |
| PASS<br>LP<br>Additional<br>Components | Titanium alloy (Ti-6AI-4V ELI,<br>following standards ASTM<br>F136 and ISO 5832-3) | Titanium alloy (Ti-6AI-4V ELI,<br>following standards ASTM F136<br>and ISO 5832-3) |

Material composition is identical to other MEDICREA® INTERNATIONAL products that have been cleared via the 510(k) process.

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### 7. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility Testing

The biocompatibility evaluation for the PASS LP system was conducted in accordance with the FDA blue book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- V Cytotoxicity
- > Sensitization
- > Irritation
- > Systemic toxicity
- > Pyrogen Testing

According to the standard ISO 10993-1, the PASS LP Spinal System is defined as implantable

device in contact with tissue and bone and as a permanent contact with the patient.

For chemical composition, the material conform toTi-6AI-4V ELI, following standards ASTM F136 and ISO 5832-3.

#### Mechanical testing

When applicable, the tests performed on the additional components (dynamic axial compression according to ASTM F1717) indicate that the products are as mechanically sound as other devices commercially available.

Clinical study

No clinical studies were performed.

Animal study

No animal studies were performed.

## 8. CONCLUSION

MEDICREA® INTERNATIONAL S.A. PASS LP Spinal System is substantially equivalent to its predicate device in terms of indications for use, design, material and function.