K Number
K180502
Device Name
S128 Anterior Lumbar Interbody Fusion (ALIF) System
Date Cleared
2018-06-14

(108 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.
Device Description
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change. The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices <20° when implanted with the coverplate and screws. Implants are offered in Ti6A14V and PEEK with Tantalum marker pins. Titanium cages are additively manufactured then machined to the final cage dimensions. PEEK implants are manufactured using traditional methods. The Ti6Al4V conforms to the chemical and mechanical requirements of ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications The PEEK is compliant with ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.The Tantalum is compliant with ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications. The S128 ALIF System cages that are the subject of this application are gamma sterilized. The system also includes instruments to allow for implant determination, trialing and disc preparation. Instruments are manufactured from stainless steel in compliance with ASTM A564/M564-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.
More Information

No
The document describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is an Anterior Lumbar Interbody Fusion (ALIF) System, which is used for intervertebral body fusion procedures to treat degenerative disc disease, indicating a therapeutic purpose.

No

The device is an Anterior Lumbar Interbody Fusion (ALIF) System, which is an implant used for intervertebral body fusion procedures. It is a treatment device, not a diagnostic one.

No

The device description clearly details physical implants (cages made of Ti6A14V and PEEK with Tantalum marker pins) and surgical instruments made of stainless steel. This indicates it is a hardware-based medical device, not software-only.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is described as an implantable device (cages, cover plate, screws) used in surgical procedures for spinal fusion. It is made of materials like Ti6A14V and PEEK.
  • Intended Use: The intended use is for intervertebral body fusion procedures in the lumbar spine. This is a surgical intervention, not a diagnostic test performed on a sample.
  • Lack of Diagnostic Function: The device itself does not perform any diagnostic function on a biological sample. It is a physical implant used to stabilize the spine.

The mention of "radiographic studies" in the intended use refers to the diagnostic information used by a clinician to determine if the patient is a candidate for the surgical procedure, not a function of the device itself.

N/A

Intended Use / Indications for Use

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

Product codes

OVD

Device Description

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change.
The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.

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Renovis Surgical Technologies Inc. % Sharyn Orton Senior Consultant MEDIcept. Inc. 200 Homer Ave Ashland, Massachusetts 01721

June 14, 2018

Re: K180502

Trade/Device Name: S128 Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 15, 2018 Received: May 16, 2018

Dear Dr. Orton:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Dr. Sharyn Orton

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Melissa Hall -S 2018.06.14 12:57:33 -04'00"

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

Enclosure

2

Indications for Use

510(k) Number (if known) K180502

Device Name

S128 Anterior Lumbar Interbody Fusion (ALIF) System

Indications for Use (Describe)

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary as required by 21 CFR 807.92(a) K180502

| A) Submitted by: | Renovis Surgical Technologies Inc.
1901 W. Lugonia Ave, Ste 340
Redlands, CA 92374
Phone: 909-557-2360
Fax: 909-307-8571 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Anthony DeBenedictis
Vice President of Quality Assurance |
| Consultant: | Sharyn Orton, Ph.D.
MEDIcept, Inc.
200 Homer Ave
Ashland, MA 01721 |
| B) Classification Name: | Intervertebral Fusion Device, Lumbar |
| Common Name: | Intervertebral body fusion device |
| Proprietary Name: | Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System |
| Device Class: | Class II |
| Regulations
and Product Code: | 21 CFR 888.3080
OVD |
| Classification panel: | Orthopedic |
| C) Predicates: | Primary: K140106 Renovis S128 Anterior Lumbar Interbody
Fusion (ALIF) System
K131122 Renovis S128 Anterior Lumbar Interbody Fusion (ALIF)
System |
| D) Date Prepared: | June 12, 2018 |

E) Device Description:

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change.

4

The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices