K Number
K121129
Device Name
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
Manufacturer
Date Cleared
2012-06-13

(61 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices may be implanted via an open or a minimally invasive transforaminal approach. The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Device Description
The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights and is made of PEEK Optima LT1. The device and associated instruments are provided non-sterile.
More Information

Not Found

No
The summary describes a passive implantable device made of PEEK for lumbar fusion. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies are limited to static compression testing.

Yes
The device is used for intervertebral body fusion in patients with degenerative disc disease, which addresses a medical condition.

No
The device is an intervertebral body fusion device, designed to facilitate fusion in patients with degenerative disc disease, not to diagnose medical conditions.

No

The device description clearly states it is a physical implant made of PEEK material, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The provided information clearly describes a physical implantable device (an intervertebral body fusion device) designed to be surgically placed in the lumbar spine to facilitate bone fusion. It is used in vivo (within the body), not in vitro (in a lab setting with specimens).

The device's function is structural support and facilitating bone growth within the body, which is fundamentally different from the purpose of an IVD.

N/A

Intended Use / Indications for Use

The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices may be implanted via an open or a minimally invasive transforaminal approach. The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

Product codes

MAX

Device Description

The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The device is available in a range of lengths and heights and is made of PEEK Optima LT1. The device and associated instruments are provided non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine from L2 to S1

Indicated Patient Age Range

skeletally mature

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Static compression testing per ASTM 2077 was performed. The results showed that the device was substantially equivalent to the identified predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Spineology PEEK Lumbar Interbody Fusion Devices (K120293)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

KIJ 129

JUN | 3 2012

510(k) Summary

| Applicant: | Spineology Inc.
7800 3rd Street N., Suite 600
Saint Paul, MN 55128
651-256-8500 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bryan Becker |
| Date Prepared: | April 9, 2012 |
| Trade Name: | Spineology PEEK Lumbar Interbody Fusion Devices |
| Product Classification
and Code: | Class II Medical Device, Product Code MAX |
| Predicate Device(s): | Spineology PEEK Lumbar Interbody Fusion Devices (K120293) |
| Reason for this 510(k) | This Special 510(k) is to add an option 4th marker to the front of the
implant. |
| Device Description: | The Spineology PEEK Lumbar Interbody Fusion Device is designed for
use with autograft to facilitate fusion and is intended for use with
supplemental fixation systems cleared for use in the lumbar spine. The
device is available in a range of lengths and heights and is made of PEEK
Optima LT1. The device and associated instruments are provided non-
sterile. |
| Intended Use: | The Spineology PEEK Lumbar Interbody Fusion Device is an
intervertebral body fusion device indicated for intervertebral body fusion
at one level or two contiguous levels in the lumbar spine from L2 to S1 in
patients with degenerative disc disease (DDD) with up to Grade I
spondylolisthesis at the involved level(s). DDD is defined as back pain of
discogenic origin with degeneration of the disc confirmed by patient
history and radiographic studies. These patients should be skeletally
mature and have had six months of non-operative treatment.
These devices may be implanted via an open or a minimally invasive
transforaminal approach.
The Spineology PEEK Lumbar Interbody Fusion Device is designed for
use with autograft to facilitate fusion and is intended for use with
supplemental fixation systems cleared by the FDA for use in the lumbar
spine. |
| Summary of
Technological
Characteristics: | The device is shown to be substantially equivalent to the intended use,
materials, configuration, and performance characteristics of the predicate
products. |

1

page 2 of 2

| Testing | Static compression testing per ASTM 2077 was performed. The
results showed that the device was substantially equivalent to the
identified predicate devices. |
|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The information submitted in this premarket notification supports a
determination that the Spineology PEEK Lumbar Interbody Fusion
Device is substantially equivalent in technological characteristics and
intended use to the predicate devices. |

2

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's body and wings.

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

JUN 1 3 2012

Spineology, Inc. % Mr. Bryan Becker Clinical and Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K121129

Trade/Device Name: Spineology PEEK Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 11, 2012 Received: May 14, 2012

Dear Mr. Becker:

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 r ou may, are ere, mains 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 I feast of a has made a determination that your device complies with other requirements of the Act

3

Page 2 - Mr. Bryan Becker

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunel Keith

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

Enclosure

4

Indications for Use Form

Device Name: The Spineology PEEK Lumbar Interbody Fusion Device

Indications for Use:

The Spineology PEEK Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI1 in patients with degenerative disc disease (DDD) with up to Grade I spondvlolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

These devices may be implanted via an open or a minimally invasive transforaminal approach.

The Spineology PEEK Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.

X AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

_
(Division Sign-Off)

Diffision of Surgical, Orthopedic, and Restorative Devices

K121129 510(k) Number_