Oyster ACIF Cage

K182608 · Silony Medical GmbH · ODP · Jun 13, 2019 · Orthopedic

Device Facts

• Record ID: K182608
• Device Name: Oyster ACIF Cage
• Applicant: Silony Medical GmbH
• Product Code: ODP · Orthopedic
• Decision Date: Jun 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

Device Story

Oyster ACIF Cage is a cervical interbody fusion implant; inserted between adjacent cervical vertebrae to facilitate fusion. Device requires supplemental anterior cervical plate fixation; used with autogenous or allogeneic bone graft. Implants available in various heights (4-10mm) and footprints. Used by surgeons in clinical settings for patients with cervical disc disease. Provides structural support to the spinal column during the fusion process; benefits patients by stabilizing the disc space and promoting bone growth.

Clinical Evidence

Bench testing only. Testing included static and dynamic axial compression, compression shear, and torsion per ASTM F2077, and subsidence testing per ASTM F2267. Results demonstrate sufficient strength for intended use.

Technological Characteristics

Material: Ti6Al4V ELI (Grade 23). Manufacturing: SLM and standard milling. Form factor: Cervical interbody cage, heights 4-10mm, three footprints. Mechanical testing per ASTM F2077 and ASTM F2267.

Indications for Use

Indicated for intervertebral body fusion in skeletally mature patients with cervical disc disease (DDD) at up to two contiguous levels (C2-T1) following at least six weeks of failed non-operative treatment. Requires use with supplemental anterior cervical plate fixation and autogenous/allogeneic bone graft.

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

• ROCCIA® ACIF (K162587)
• EIT Cellular Titanium® Cervical Cage (K172888)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

Silony Medical GmbH % Ms. Meredith May Vice President Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918

Re: K182608

Trade/Device Name: Oyster ACIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: May 13, 2019 Received: May 14, 2019

Dear Ms. May:

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

June 13,2019

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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 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 (QS) 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 medical devices and radiation-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 Melissa Hall 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br>Indications for Use | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement on last page. |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | |
| K182608 | |
| Device Name | |
| Oyster ACIF Cage | |
| Indications for Use (Describe) | |

The Oyster ACIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster ACIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster ACIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

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

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# K182608 - 510(K) SUMMARY

| Submitter's Name: | Katharina Barsch<br>Silony Medical GmbH |
|----------------------------|--------------------------------------------------------------------------------------------------|
| Submitter's Address: | Leinfelder Straße 60<br>Leinfelden-Echterdingen, Germany D-70771 |
| Submitter's Telephone: | [phone] |
| Additional Contact Person: | Meredith Lee May MS, RAC<br>Empirical Consulting<br>719.337.7579<br>[e-mail] |
| Date Summary was Prepared: | 18 Sep 2018 |
| Trade or Proprietary Name: | Oyster ACIF Cage |
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | ODP |
| Classification Panel: | Abdominal and Surgical Devices Branch (ASDB) |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Oyster cages are Cervical Interbody Fusion cages and have been developed for at up to two contiguous levels from C2 to T1. It is intended for insertion between two adjacent cervical vertebrae. The implants are offered in heights from 4 to 10mm, and 3 footprints (14mm x 15mm, 16mmx17mm, 14mmx17mm). The implants are manufactured by SLM and standard milling process.

## INDICATIONS FOR USE

The Oyster CIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The Oyster CIF Cage is intended for use for anterior cervical interbody fusion in patients with cervical disc disease (DDD) at up to two contiguous levels from C2 to T1. The System is intended to be used with supplemental fixation; the Oyster CIF Cage device is required to be used with an anterior cervical plate as the form of supplemental fixation. The System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.

#### TECHNOLOGICAL CHARACTERISTICS

Oyster ACIF Cage is made from Ti6Al4V ELI (Grade 23). The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

- Materials of manufacture ●

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- Structural support mechanism ●
- Manufacturing methods ●

| 510k Number | Trade or Proprietary or<br>Model Name | Manufacturer | Predicate<br>Type |
|-------------|-----------------------------------------|-------------------------------------------|-------------------|
| K162587 | ROCCIA® ACIF | Silony Medical GmBH | Primary |
| K172888 | EIT Cellular Titanium®<br>Cervical Cage | EIT Emerging Implant<br>Technologies GmbH | Additional |

#### PERFORMANCE DATA

The Oyster ACIF Cage has been tested in the following test modes:

- . Static Axial Compression per ASTM F2077
- Static Compression Shear per ASTM F2077 ●
- Static Torsion per ASTM F2077
- Dynamic Axial Compression per ASTM F2077 ●
- . Dynamic Compression Shear per ASTM F2077
- Dynamic Torsion per ASTM F2077 .
- Subsidence per ASTM F2267 .

The results of this non-clinical testing show that the strength of the Oyster ACIF Cage is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

#### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Oyster ACIF Cage is substantially equivalent to the predicate device.