CarboClear Lumbar Cage System

K203683 · Carbofix Orthpedics , Ltd. · MAX · Jan 15, 2021 · Orthopedic

Device Facts

• Record ID: K203683
• Device Name: CarboClear Lumbar Cage System
• Applicant: Carbofix Orthpedics , Ltd.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 15, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels. CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine. Patients should have at least six months of non-operative treatment prior to surgery.

Device Story

CarboClear® Lumbar Cage System consists of implants of various sizes and lordotic angles used for intervertebral body fusion. Implants are placed in the intervertebral disc space to maintain disc height and facilitate fusion. Used with autogenous or allogenic bone graft and supplemental fixation. Intended for use in clinical settings by surgeons. Benefits include stabilization of the lumbar spine in patients with degenerative disc disease.

Clinical Evidence

No clinical data. Performance evidence is based on bench testing, including finite element analysis and mechanical testing (ASTM F2077 and expulsion testing) to demonstrate substantial equivalence.

Technological Characteristics

Implants composed of carbon fiber-reinforced polyetheretherketone (CFR-PEEK) with titanium alloy endplates. System includes various sizes and lordotic angles. Mechanical performance validated per ASTM F2077.

Indications for Use

Indicated for intervertebral body fusion of lumbar spine (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis. Requires 6 months of prior non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• CarboClear® Lumbar Cage System (K193378)
• CONCORDE® Bullet Lumbar Interbody System (K151773)
• FORZA® PTC Spacer System (K152475)
• icotec Interbody Cage System (K172480)
• eCarbon-P IBD (K191537)
• Tritanium® PL Posterior Lumbar Cage (K152304)

Submission Summary (Full Text)

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January 15, 2020

CarboFix Orthpedics Ltd. Hila Wachsler-Avrahami Regulatory Affairs 11 Ha'Hoshlim Street Herzeliya, 4672411 Israel

Re: K203683

Trade/Device Name: CarboClear® Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 14, 2020 Received: December 17, 2020

Dear Hila Wachsler-Avrahami:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Brent Showalter, Ph.D. 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)

K203683

Device Name

CarboClear® Lumbar Cage System

#### Indications for Use (Describe)

The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.

CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine .

Patients should have at least six months of non-operative treatment prior to surgery.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

# CarboFix Orthopedics Ltd. CarboClear® Lumbar Cage System

# Applicant Name

CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel

# Contact Person

Hila Wachsler-Avrahami CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzeliya 4672411, Israel Tel: [phone], Fax: [phone]

# Date Prepared

December 14, 2020

### Trade/Proprietary Name

CarboClear® Lumbar Cage System

# Common Name

Intervertebral Body Fusion Device

# Regulation Number and Device Class

21 CFR §888.3080; Class II

# Product Code and Review Panel

MAX; Orthopedic

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#### Predicate Devices

#### Primary Predicate Device:

CarboClear® Lumbar Cage System (CarboFix Orthopedics Ltd.; K193378)

#### Additional Predicate Devices:

- " CONCORDE® Bullet Lumbar Interbody System (DePuy Spine, Inc .; K151773)
- FORZA® PTC Spacer System (Orthofix Inc.; K152475)
- icotec Interbody Cage System (icotec ag: K172480)
- eCarbon-P IBD (Back 2 Basics Direct, LLC; K191537)
- Tritanium® PL Posterior Lumbar Cage (Striker; K152304)

### Intended Use/Indications for Use

The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.

CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.

Patients should have at least six months of non-operative treatment prior to surgery.

### System Description

CarboClear® Lumbar Cage System is composed of implants of various sizes and lordotic angles, and instruments.

The CarboClear® Lumbar Cage is made of carbon fiber-reinforced polyetheretherketone (CFR-PEEK), with titanium alloy endplates. It is implanted in the intervertebral disc space with bone graft and is designed to maintain disc height and to facilitate vertebral fusion. The CarboClear® Lumbar Cage System should be used with a supplemental fixation system.

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#### Purpose of Submission

The purpose of this Special 510(k) Premarket Notification is to add lordotic lumbar cages to the CarboClear® Lumbar Cage System.

### Performance Data and Substantial Equivalence

The intended use, design, material, dimensions, technological characteristics, and principles of operation of the subject CarboClear® Lumbar Cage System are substantially equivalent to those of the predicate devices.

Performance characteristics included finite element analysis with supportive testing according to ASTM F2077 and expulsion test. The results of the analysis/tests are comparable to those of the predicate devices, demonstrating substantially equivalent mechanical performance of the subject device.

# Conclusion

Based on the information provided in this Premarket Notification, the subject CarboClear® Lumbar Cage System is substantially equivalent to its predicate devices.