LIGAPASS

K132395 · Medicrea International · OWI · Dec 6, 2013 · Orthopedic

Device Facts

• Record ID: K132395
• Device Name: LIGAPASS
• Applicant: Medicrea International
• Product Code: OWI · Orthopedic
• Decision Date: Dec 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ligapass is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilziation as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications: - Spinal trauma surgery, used in sublaminar,or facet wiring techniques; - Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis; - Spinal degenerative surgery, as an adjunct to spinal fusions;

Device Story

LigaPASS is a temporary orthopedic implant system used by surgeons to provide stabilization during bony fusion or fracture repair. The device consists of a connector body, rod set screw, locking set screw, and a polyester band. It functions as a bone anchor, connecting a spinal rod (5.5mm or 6mm) to a vertebra. The surgeon uses the device in the OR to secure spinal constructs, often in conjunction with other titanium or cobalt chrome implants. By tightening the rod and bone anchor independently, the system provides mechanical stability to the spine, aiding in deformity correction or fusion. The device is intended for use in spinal trauma, reconstructive, and degenerative surgeries.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical mechanical testing (ASTM F1717 and ASTM F1798) comparing the subject device to the predicate LigaPASS (K112736).

Technological Characteristics

Connectors made of titanium alloy (ASTM F136/ISO 5832-3); band made of polyethylene terephthalate (PET) and pure titanium (ASTM F67). Mechanical fixation via rod and bone anchor connectors. Compatible with 5.5mm or 6mm rods. Non-active, mechanical implant.

Indications for Use

Indicated for patients 10 years of age and older requiring spinal stabilization. Applications include spinal trauma surgery (sublaminar/facet wiring), spinal reconstructive surgery (idiopathic/neuromuscular scoliosis, adult scoliosis, kyphosis), and spinal degenerative surgery (adjunct to spinal fusions).

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Universal Clamp Spinal Fixation System (K110348)
• LigaPASS (K112736)

Submission Summary (Full Text)

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### 510(k) Summary for the MEDICREA® INTERNATIONAL LigaPASS

| 1. GENERAL INFORMATION | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 510(k) | Traditionnal |
| Date Prepared | December 05, 2013 |
| Trade Name | LigaPASS |
| Common Name | ✓ Bone Fixation Cerclage, Sublaminar |
| Classification Name | ✓ Bone Fixation Cerclage per OWI 888.3010 |
| Class | Class II |
| Product Code | OWI |
| CFR section | 888.3010 |
| Device panel | Orthopedic |
| Legally marketed predicate devices | Universal Clamp Spinal Fixation System (Zimmer Spine)= K110348<br>LigaPASS (MEDICREA INTERNATIONAL) = K112736 |
| Submitter | MEDICREA International<br>14 Porte du Grand Lyon<br>01700 Neyron, France |
| Contact Person | Audrey VION<br>14 Porte du Grand Lyon<br>01700 NEYRON<br>FRANCE<br>[phone]<br>E-mail : [e-mail] |

#### 2. PREDICATE DEVICE DESCRIPTION

, The Universal Clamp System (K110348) and LigaPASS (K112736) are temporary orthopedic implants intended to provide stabilization during the development of solid bony fusion and aid in the repair of bone fractures. The Universal Clamp System (K110348) and LigaPASS (K112736) are designed to be incorporated into constructs and used in conjunction with other medical implants.

The indications for use for the Universal Clamp System (K110348) include, but are not limited to, the following applications: Spinal trauma surgery; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis and, spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions.

The indications for use for the LigaPASS (K112736) include, but are not limited to, the following applications: Spinal trauma surgery, Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions.

The Universal Clamp System (K110348) and LigaPASS (K112736) may also be used with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

#### 3. DEVICE DESCRIPTION

The LigaPASS connectors connect a rod to a vertebra. These connectors can independently tighten the rod and the bone anchor. The LigaPASS connectors are composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

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#### 4. INTENDED USE

The ligapass is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilziation as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:

- Spinal trauma surgery, used in sublaminar,or facet wiring techniques;

- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;

- Spinal degenerative surgery, as an adjunct to spinal fusions;

# 5. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

MEDICREA® INTERNATIONAL LigaPASS is substantially equivalent to the ZIMMER SPINE Universal Clamp® System (K110348), in terms of intended use, materials used, mechanical safety and performances.

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| Device | Universal Clamp® System<br>(ZIMMER SPINE) | LigaPASS |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K110348 | In progress |
| Intended use | The Universal Clamp® System is a<br>temporary implant for use in<br>orthopedic surgery. The system is<br>intended to provide temporary<br>stabilization as a bone anchor<br>during the development of solid<br>bony fusion and aid in the repair of<br>bone fractures. The indications for<br>use include, but are not limited to,<br>the following applications:<br>Spinal trauma surgery, used in<br>sublaminar, interspinous, or facet<br>wiring techniques;<br>Spinal reconstructive surgery,<br>incorporated into constructs for the<br>purpose of correction of spinal<br>deformities such as scoliosis,<br>kyphosis, spondylolisthesis;<br>Spinal degenerative surgery, as an<br>adjunct to spinal fusions;<br>The universal Clamp® System may<br>also be used in adjunction with<br>other medical implants made of<br>titanium alloy whenever "wiring"<br>may help secure the attachment of<br>other implants. | The LigaPASS is a temporary<br>implant for use in orthopedic<br>surgery. The system is intended to<br>provide temporary stabilization as<br>a bone anchor during the<br>development of solid bony fusion<br>and aid in the repair of bone<br>fractures. LigaPASS system is<br>indicated for the following<br>applications:<br>- Spinal trauma surgery, used in<br>sublaminar, or facet wiring<br>techniques;<br>- Spinal reconstructive surgery,<br>incorporated into constructs for<br>the purpose of correction of<br>spinal deformities such as<br>idiopathic and neuromuscular<br>scoliosis in patients 10 years of<br>age and older, adult scoliosis, and<br>kyphosis;<br>- Spinal degenerative surgery, as<br>an adjunct to spinal fusions;<br><br>LigaPASS system may also be used<br>in conjunction with other medical<br>implant grade implants made of<br>titanium or cobalt chrome alloy<br>whenever "wiring" may help<br>secure the attachment of other<br>implants. |
| Design | | |
| Components | Connector with polyester band:<br>To circle a vertebra as a bone<br>anchor and connect to a Ø5.5mm<br>or Ø6mm rod. | Connectors with polyester band:<br>To circle a vertebra as a bone anchor<br>and connect to a Ø5.5mm or Ø6mm<br>rod. |
| Range | A connector and a band. | Connectors and a band. |
| Materials | | |
| Device | Universal Clamp System<br>(ZIMMER SPINE) | LigaPASS |
| | Universal clamp system is made<br>from titanium alloy conforming to<br>ASTM F136 or ISO 5832-3, with the<br>exception of the band which is<br>manufactured from polyethylene<br>terephtalate (PET) and pure<br>titanium conforming to ASTM F67. | LigaPASS connectors are made from<br>titanium alloy conforming to ASTM<br>F136 or ISO 5832-3, with the<br>exception of the band which is<br>manufactured from polyethylene<br>terephtalate (PET) and pure titanium<br>conforming to ASTM F67. |

・

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

#### 6. NON-CLINICAL TEST SUMMARY

The LigaPASS submitted by MEDICREA in this 510(k) includes components that have been approved by the FDA in the previous 510(k) (K112736) for the following indications:

The LigaPASS is a temporary implant for use in orthopedic surgery on skeletally mature patients. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

- Spinal trauma surgery, used in sublaminar, interspinous, or facet wiring techniques; .
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of . spinal
- deformities such as scoliosis, kylphosis, spondylolisthesis;Spinal degenerative surgery, as an . adjunct to spinal fusions;

The LigaPASS may also be used in conjunction with other medical implants made of titanium or cobalt chrome alloy whenever "wiring" may help secure the attachment of other implants.

The purpose of this new submission is to extend the indications for use to idiopathic and neuromuscular scoliosis treatment in patients 10 years of age and holder. No other changes in terms of design characteristics, principles of operation, packaging, sterility, biocompatibility or mechanical performances have undergone.

Mechanical testing of the MEDICREA - INTERNATIONAL LigaPASS implants was conducted following the ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and following the ASTM F1798 "Standard Guide for Evoluating the Static and Fotigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants" to characterize their mechanical properties. These data was compared to the mechanical performance for other devices cleared for surgical fixation of the skeletal system (LigaPASS, MEDICREA INTERNATIONAL, K112736).

Accordingly, the mechanical performance of MEDICREA INTERNATIONAL LigaPASS implants has been established via these cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736).

#### 7. CLINICAL TEST SUMMARY

No clinical studies were performed.

# 8. CONCLUSIONS: NON-CLINICAL AND CLINICAL

The LigaPASS is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 6, 2013

Medicrea International Ms. Audrey Vion Regulatory Affairs Manager 14 Porte du Grand Lyon 01700 Neyron France

Re: K132395

Trade/Device Name: LigaPASS Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: November 7, 2013 Received: November 12, 2013

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 of medical

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## Page 2 -- Ms. Audrey Vion

device-rclated 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.

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 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 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.

Lori A. Wigqins

for

:

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

Enclosure

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510(k) Number (if known): ___ Device Name: LigaPASS

#### INDICATIONS FOR USE

K132395

The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for the following applications:

- Spinal trauma surgery, used in sublaminar, or facet wiring techniques;

- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 10 years of age and older, adult scoliosis, and kyphosis;

- Spinal degenerative surgery, as an adjunct to spinal fusions;

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132395