K Number

Device Name

SPINEFRONTIER LUMBAR IBF SYSTEM

Manufacturer

SPINEFRONTIER, INC.

Date Cleared

2011-09-28

(117 days)

Product Code

MAX

Regulation Number

888.3080

Intended Use

The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Dorado ALIFT, Dorado TILT, Dorado TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients mav also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

Device Description

The SpineFrontier Lumbar IBF System is a spinal intervertebral body fusion device system intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The system is comprised of devices made of PEEK Optima® LT1, with varying widths, lengths, and heights to fit the anatomical needs of patients. The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K072289, K091638, K092815

Reference Devices

K071724

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

Yes

The device is intended for intervertebral body fusion of the spine to treat degenerative disc disease, which is a medical condition. This aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.

Diagnostic

The device is an intervertebral body fusion system intended for surgical implantation to facilitate spinal fusion, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is comprised of devices made of PEEK Optima® LT1, which is a material used for physical implants. The performance studies also focus on mechanical testing of the physical device.

IVD (In Vitro Diagnostic)

Based on the provided text, 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: The description clearly states that this is a physical implantable device made of PEEK Optima® LT1, intended for surgical implantation in the spine.
Intended Use: The intended use is for intervertebral body fusion of the spine, a surgical procedure, not a diagnostic test performed on a sample.
Lack of IVD Characteristics: The text does not mention any analysis of biological samples, reagents, or diagnostic purposes.

Therefore, the SpineFrontier Lumbar Interbody Fusion Device System is a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIF, Dorado ELIF, Dorado ALIF, Dorado TILT, Dorado TLIF, Dorado Wide, and Ursa S-LIF) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

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

MAX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spine, L2-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)

The SpineFrontier Lumbar Intervertebral Body Fusion Device System was evaluated in accordance with FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing). Clinical data was not required for this device. Mechanical testing includes performance assessments per the following recognized test methods:

ASTM F2077-03, Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
ASTM F2267-04, Subsidence Under Static Axial Compression
ASTM Draft Standard F-04.25.02.02, Static Expulsion

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.

K072289, K091638, K092815

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.

K071724

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

Regulation Number and Section

§ 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.

Summary

SEP.

2 8 2011

5.0 510(k) Summary

1. Sponsor

SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915

Primary Contact:	Hannah Foley
Telephone:	1- 978-232-3990

Mav 9, 2011 Date Prepared:

2. Device Name and Classification:

Proprietary Name:	SpineFrontier Lumbar IBF System
Common/Usual Name:	Intervertebral Fusion Device With Bone Graft,
Lumbar
Classification Name:	Intervertebral Fusion Device With Bone Graft,
Lumbar, (21 CFR 888.3080), Class II
Product Code:	MAX

3. Predicate Devices

This 510(k) submission provides notice of design changes being implemented to SpineFrontier's Dorado, Dorado Wide, and SLIF intervertebral body fusion devices and to create the SpineFrontier Lumbar IBF System. These modifications do not alter the fundamental technology of the predicate device or the devices' intended use.

K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K091638 - SpineFrontier Inc., Dorado Wide IBF K092815 - SpineFrontier Inc., S-LIF IBF K071724 - Spinal Elements, Lucent

4. Device Description

1. Intended Use

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

6. Technological Characteristics

The SpineFrontier Lumbar Intervertebral Body Fusion Device System was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials.

7. Basis for Substantial Equivalence

ASTM F2077-03, Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
ASTM F2267-04, Subsidence Under Static Axial Compression
ASTM Draft Standard F-04.25.02.02, Static Expulsion -

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、 ! . : . . Document Control Room - WOnb-Group Silver Spaing MHz 20093-000)2

SpineFrontier, Inc. % Ms. Hannah Foley Manager of OA and Regulatory Compliance 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915

SEP 2 8 2011

Re: K111553

Trade/Device Name: Lumbar IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 07. 2011 Received: September 09, 2011

Dear Ms. Foley:

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

Page 2 -- Ms. Framman Polev

comply with all the Act s requirements, including, bat 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 vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Abouti-DA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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/McdicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarker 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/Indusury/default.htm.

Sincerely yours.

Ernst Keith

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

Enclosure

510(k) Number (if Known):

SpineFrontier Lumber Interbody Fusion Device System Device Name:

Indications For Use:

The SpineFrontier Lumbar Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.

Prescription Use: X

Over-The-Counter Use: (Part 21 CFR 807.109)

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

'LE W'H U: THU TA ® TRA TP 에 대 유 파 파 파 파 파 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 바 Concurrence of CDRH, Office of Device Evaluation (ODE)

Director Sign-Off

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

KIII 553 510(k) Number_