STERISPINE LC CAGE

K151756 · Safe Orthopaedics · MAX · Aug 21, 2015 · Orthopedic

Device Facts

• Record ID: K151756
• Device Name: STERISPINE LC CAGE
• Applicant: Safe Orthopaedics
• Product Code: MAX · Orthopedic
• Decision Date: Aug 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.

Device Story

SteriSpine™ LC Cage is an intervertebral body fusion device designed for lumbar spinal fusion. Available in straight (TLIF/PLIF) or curved (TLIF) configurations, the cage features a central cavity for autogenous bone graft to promote fusion. Implants are constructed from PEEK with Tantalum markers for radiographic visualization. The system is supplied sterile as a single-use kit, including surgical instruments. Used by surgeons in clinical settings, the device is implanted during spinal fusion procedures to stabilize the disc space. The cage acts as a structural spacer, maintaining disc height while fusion occurs. The current submission introduces modified bifunctional instruments, a redesigned quick-change handle, and barium sulfate in specific instruments to enhance visibility. The device is intended to be used in conjunction with the SteriSpine™ PS supplemental fixation system.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5, -10, and -11. Packaging validation per ISO 11607-1 and -2. Sterilization revalidation per ISO 11137-1, -2, and -3.

Technological Characteristics

Implant material: PEEK (Zeniva ZA-500, ASTM F2026) with Tantalum markers (ASTM F560). Instruments: Barium sulfate added to dual trial and dual spreader for radiopacity. Supplied sterile, single-use. No changes to implant design; modifications limited to surgical instrumentation and packaging.

Indications for Use

Indicated for intervertebral body fusion at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis. Requires 6 months of failed non-operative treatment. Must be used with autogenous bone graft and SteriSpine™ PS supplemental fixation.

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

• STERISPINET™ LC CAGE (K133893)
• STERISPINE™ LC CAGE (K122021)

Submission Summary (Full Text)

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

August 21, 2015

Safe Orthopaedics Mr. Pierre Dumouchel QARA Director Parc des Bellevues Allée R. Luxembourg - Bat. Californie 95610 Eragny Sur Oise France

Re: K151756

Trade/Device Name: STERISPINETM LC Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 25, 2015 Received: June 29, 2015

Dear Mr. Dumouchel:

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

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## Page 2 - Mr. Pierre Dumouchel

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.

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 yours.

# Mark N. Melkerson -S

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

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

K151756

Page 1 of 1

510(k) Number (if known) K151756

Device Name STERISPINE™ LC CAGE

#### Indications for Use (Describe)

The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.

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)

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

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# STERISPINE™ LC CAGE

Image /page/3/Picture/1 description: The image shows the logo for SafeOrthopaedics. The logo features a stylized letter 'S' in a light green color, with a small dot to the right of the 'S'. Below the 'S', the text 'SafeOrthopaedics' is written in a sans-serif font, with the word 'Safe' in a lighter shade of green than the word 'Orthopaedics'.

# 510(k) SUMMARY

| 510k | Traditional |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by | Safe Orthopaedics<br>Parc des Bellevues<br>Allée R. Luxembourg - Le Californie<br>95610 Eragny sur Oise - FRANCE |
| Contacts | Pierre DUMOUCHEL Industrialization Director / QARA Director<br><a href="mailto:[e-mail]">[e-mail]</a><br>[phone]<br>Isabelle Drubaix Regulatory contact<br><a href="mailto:[e-mail]">[e-mail]</a><br>[phone] |
| Date Prepared | June 3rd 2015 |
| Common Name | Intervertebral body fusion device |
| Trade Name | STERISPINET™ LC CAGE |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate device: STERISPINET™ LC CAGE manufactured by Safe<br>Orthopaedics cleared under K133893<br>Additional predicate device: STERISPINE™ LC CAGE manufactured by<br>Safe Orthopaedics cleared under K122021 |
| Indications for use | The SteriSpine™LC device is indicated for intervertebral body fusion<br>procedures at one or two contiguous levels from L2 to S1 in skeletally<br>mature patients with degenerative disc disease (DDD) with up to Grade I<br>spondylolisthesis at the involved level(s). DDD is defined as discogenic<br>back pain with degeneration of the disc confirmed by patient history and<br>radiographic studies. Patients should have at least six (6) months of<br>non-operative treatment prior to treatment with an intervertebral cage.<br>This device is to be used with autogenous bone graft to facilitate fusion<br>and is intended for use with SteriSpine™ PS, a supplemental fixation<br>system cleared by the FDA for use in the lumbar spine. |

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| Description of the device | The SteriSpine™LC cages are intervertebral body fusion devices with a<br>central cavity available either in straight rectangular shape for<br>transforaminal (TLIF) or posterior (PLIF) approach and in curved shape<br>for transforaminal (TLIF) approach. The SteriSpine™LC cages are made<br>of PEEK (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum<br>markers conforming ASTM F560 to visualize the position of the implant<br>in the disc space. The SteriSpine™LC cages are available in several sizes<br>to adapt to anatomical variations. The SteriSpine™LC range of products<br>is supplied sterile with a sterile single-use set of surgical instruments. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | There have been no changes made to the SteriSpine™LC implants<br>(K122021 and K133893). The purpose of this 510(k) submission is to<br>obtain clearance for added bifunctional instruments to the<br>SteriSpine™LC sterile single-use set of surgical instruments, and for a<br>redesigned quick change handle. Additionally, sulfate barium has been<br>added in the raw material of the dual trial and the dual spreader in order<br>to improve visibility. Finally, a "window" has been added to the external<br>packaging of SteriSpine™LC devices supplied sterile. This new packaging<br>will be used for all devices manufactured by Safe Orthopaedics. |
| Discussion of Testing | The following non-clinical tests were conducted: biocompatibility testing<br>according to ISO 10993-5, ISO 10993-10 and ISO 10993-11 for the new<br>or modified raw materials; packaging validation according to ISO 11607-<br>1 and 11607-2 and sterilization revalidation according to ISO 11137-1,<br>11137-2 and 11137-3. Results demonstrate that the performance of the<br>subject device system is substantially equivalent to the cited predicates. |
| Conclusion | Non clinical performance testing demonstrates that the added or<br>modified surgical instruments are substantially equivalent to predicate<br>devices in terms of intended use, materials, design and function. |