K Number
K150206
Device Name
InFill Interbody Fusion Devices
Date Cleared
2015-04-03

(64 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.
Device Description
The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only.
More Information

Not Found

No
The document describes a physical implantable device and its mechanical testing, with no mention of AI or ML technologies.

Yes.

The device is indicated for intervertebral body fusion of the spine for the treatment of degenerative disc disease (DDD) and is designed for use with bone graft to facilitate fusion, which aims to alleviate pain and restore function in patients, making it a therapeutic device.

No

The device description indicates it is a radiolucent implantable device for intervertebral body fusion, and its intended use is for treatment of degenerative disc disease, not for diagnosis.

No

The device description explicitly states it is a radiolucent implantable device manufactured from PEEK and tantalum, which are physical materials, not software.

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

Here's why:

  • IVD Definition: 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 and Intended Use: The InFill® interbody fusion device is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. Its purpose is structural support and promoting bone growth, not analyzing biological samples.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.

Therefore, the InFill® interbody fusion device falls under the category of a medical device (specifically, an implantable surgical device), not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

Product codes (comma separated list FDA assigned to the subject device)

MAX

Device Description

The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill® interbody fusion device is provided sterile, for single use only.

The modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device. An additional length (26mm) has been added to the product family.

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 patients

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)

An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133721

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.

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

Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine Consultant 1601 Elm Street, Suite 300 Dallas, Texas 75201

Re: K150206

Trade/Device Name: InFill® Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 10, 2015 Received: March 12, 2015

Dear Ms. Pine:

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

April 3, 2015

1

Page 2 - Ms. Rebecca K. Pine

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known)Form Approved: OMB No. 0910-0120
K150206Expiration Date: January 31, 2017
See PRA Statement below.
Device Name
InFill® Interbody Fusion Devices
Indications for Use (Describe)
InFill® interbody fusion device is indicated for intervertebral body fusion of the spine in skeletally mature patients.
InFill® interbody fusion device is designed for use with autogenous bone graft to facilitate fusion. InFill® interbody
fusion device is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the
treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of
discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to
be used in patients who have had at least six months of non-operative treatment. InFill® interbody fusion device is
intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar
spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches
include anterior, lateral and transforaminal.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)Page 1 of 1PSC Publishing Services (301)-443-6740EP
---------------------------------------------------------------------------------

3

6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:Pinnacle Spine Group, LLC
DATE PREPARED:March 9, 2015
CONTACT PERSON:Rebecca K Pine
1601 Elm Street, Suite 300
Dallas, TX 75201
Phone: 760.809.5178
Fax: 760.290.3216
TRADE NAME:InFill® Interbody Fusion Devices
COMMON NAME:Spinal Implant
CLASSIFICATION
NAME:Intervertebral Body Fusion Device
DEVICE
CLASSIFICATION:Class 2, per 21 CFR 888.3080
PRODUCT CODEMAX

PREDICATE DEVICES: (primary) InFill® Interbody Fusion Device (K133721)

Substantially Equivalent To:

The modified InFill® Interbody Fusion Device is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill® Interbody Fusion Device cleared under premarket notification K133721.

Description of the Device Subject to Premarket Notification:

The InFill® interbody fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient.

The InFill® interbody fusion device is provided sterile, for single use only.

Indication for Use:

InFill® is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill® is designed for use with autogenous bone graft to facilitate fusion. InFill® is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative

4

treatment. InFill® is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior, lateral and transforaminal.

Technical Characteristics:

The modified InFill® intervertebral body fusion device has similar physical and technical characteristics to the predicate device. An additional length (26mm) has been added to the product family.

| Technical
Characteristics | InFill® interbody
fusion devices,
(41-TLIF convex,
42-TLIF lordotic
oblique; 43-TLIF
Contour) | InFill® interbody
fusion device (41-
TLIF convex, 42-
TLIF lordotic
oblique; 43-TLIF
Contour)
(K133721) |
|-------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Shape | Box-shaped, bullet
nose
Banana-shaped,
bullet nosed | SAME |
| Bone to implant
surface | Surface teeth | SAME |
| Bone graft
support feature | Central
fenestration | SAME |
| Primary implant
material | PEEK OPTIMA
LT1 ® | SAME |
| Surgical
Approach | Transforaminal | SAME |
| Lengths | 42-TLIF
26mm
28mm
30mm

43-TLIF
26mm
28mm
30mm
32mm
34mm | 42-TLIF
30mm

43-TLIF
28mm
30mm
32mm
34mm |
| Heights | 41-TLIF
8-16mm

42-TLIF
8-16mm | 41-TLIF
8-12mm
14mm
16mm

42-TLIF
8-10mm
12mm
14mm
16mm |

5

Performance Data:

An FEA (Finite Element Analysis) was performed to assess the introduction of the new InFill device sizes into the existing product family. The worst case construct was identified and characterized. The results of the analysis demonstrated that no new mechanical testing is required. The analysis demonstrated the substantial equivalence of the new device sizes to the predicate device. The modified InFill® intervertebral body fusion device met all specified criteria and did not raise new safety or performance questions.

Basis for Determination of Substantial Equivalence:

The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill® interbody fusion device is found to have a safety and effectiveness profile that is similar to the predicate device and is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the InFill® interbody fusion device (K133721).