OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)

• K Number: K043349
• Device Name: OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
• Manufacturer: LDR SPINE USA
• Date Cleared: 2005-06-29 ( 205 days)
• Product Code: MQP
• Regulation Number: 888.3060

Intended Use

The ROI is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to L5) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Device Description

The ROI vertebral implants consists of a series of flat and wedge shaped implants. The device is used singly or in pairs. The device is offered in nine different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy. The LDR Spine USA, ROI Partial Vertebral Body Replacement System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The LDR Spine ROI Partial Vertebral Body Replacement System is a two piece, hollow chamber, rectangular block. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes in various sizes and is offered in both straight and tapered styles.

Predicate Devices

K042268, K031757, K041888

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical implant device made of PEEK with specific shapes and features for vertebral body replacement. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.

Therapeutic

No
The device is a partial vertebral body replacement system, and while it aids in restoring anatomical structure, its primary function is not to treat or cure a disease or condition in a therapeutic sense, but rather to replace resected bone due to tumor or trauma/fracture. It's a structural implant.

Diagnostic

No
This device is a surgical implant designed to replace a resected vertebral body; its function is replacement, not diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is comprised of physical components fabricated from PEEK and Tantalum wire markers, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to physically replace a vertebral body in the spine due to tumor or trauma/fracture. This is a surgical implant, not a test performed on biological samples to diagnose a condition.
• Device Description: The device is a physical implant made of PEEK and Tantalum, designed to provide structural support in the spine. It does not involve any reagents, assays, or analysis of biological specimens.
• Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical and structural.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ROI is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

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

MQP

Device Description

The ROI vertebral implants consists of a series of flat and wedge shaped implants. The device is used singly or in pairs. The device is offered in nine different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy.

The LDR Spine USA, ROI Partial Vertebral Body Replacement System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.

The LDR Spine ROI Partial Vertebral Body Replacement System is a two piece, hollow chamber, rectangular block. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes in various sizes and is offered in both straight and tapered styles.

Implant grade PolyEtherEther-Ketone polymer (PEEK) with tantalum alloy position markers.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracolumbar spine (from TI to LS)

Indicated Patient Age Range

Not Found

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)

Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the predicate devices.

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.

K042268, K031757, K041888

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

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.

Summary

0

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	IDD Car
510(k)
Summarv	Spine USA
	JUNE 9, 2005
Premarket Notification, Section 510(k)

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:

Radiotransparent Open Implant (ROI) - Partial Vertebral Body Trade Name: Replacement (PVBR)

Common Vertebral body replacement Name(s):

Classification Name(s): Vertebral body replacement (MQP)

Establishment Name & Registration Number: 2.

Name:	LDR Spine USA
Number:	3004903783

3. Classification(s):

21 CFR § Sec. 888.3060 Spinal intervertebral body fixation orthosis.

(a) Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of vertebral bodies. An eve-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.

Device Class: Class II for the requested indications Classification Panel: Orthopaedic and Rehabilitation Devices Panel Product Code(s): MQP

4. Equivalent Predicate Device:

LDR Spine USA proposes that the ROI is substantially equivalent to the following:

• -EBI CAS Spine Spacer System- K042268
• -Signus PEEK Tetris™ Spinal Implant - K031757
• Signus Curved PEEK Tetris™ Spinal Implant K041888 -

Equivalence is demonstrated in the design, material composition, surgical technique and intended use.

ર્ડ Device Description:

The ROI vertebral implants consists of a series of flat and wedge shaped implants. The device is used singly or in pairs. The device is offered in nine different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy.

The LDR Spine USA, ROI Partial Vertebral Body Replacement System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.

The LDR Spine ROI Partial Vertebral Body Replacement System is a two piece, hollow chamber, rectangular block. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes in various sizes and is offered in both straight and tapered styles.

ROI.doc

1

Materials: all implants are made from implant grade PolyEtherEther-Ketone polymer (PEEK) with tantalum alloy position markers as indicated in the table below:

| PEEK
Optima LT | USP Class VI
ASTM F-2026 | ISO 10993 |
|-------------------|-----------------------------|------------|
| Tantalum | ASTM F-560 | ISO 5832-3 |

Indications for Use. The ROI is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Testing Summary. Fatigue and static testing is complete. Samples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the predicate devices.

Applicant Name & Address: 6.

LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX. 78759

Office: [phone] Fax: [phone]

7. Company Contact:

Mr. Edward E. Newton Dir. Reg. & Clinical Affairs LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX. 78759 Office: [phone] Fax: [phone]

8. Submission Correspondent:

Mr. Brian Burkinshaw Dir. Innovation & Technology LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX. 78759 Office: [phone] Fax: [phone]

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTNA LIDR Spine, USA Standard Operating Procedures, vendor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 13485 series quality regulations.

LDR Spine USA also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

ROl.doc

2

Storage, Packaging & Sterilization Information: 10.

The implantable portions of the ROI are supplied "STERILE". The sterilization process is radiation and the selected protocol has been validated. The minimum Sterility Assurance Level (SAL) of at least 10 .

The instruments are supplied non-sterile and must be cleaned and sterilized prior to first use and each The recommended sterilization process for the instruments is high temperature steam subsequent use. autoclave sterilization. The referenced sterilization cycle produces a Sterility Assurance Level (SAL) of at least 10-6.

The validated cycle is:

Method: Steam Cycle: Gravity Temperature: 270°F (134°C) Exposure Time: 18 minutes

All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

| FEATURE | ROI | CAS Spine Spacer System | PEEK and Curved PEEK
Tetris™ Spinal Implant | SE? |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indications for
Use: | The ROI is indicated for use to
replace a vertebral body that has
been resected or excised due to
tumor or trauma/fracture. The
device is intended for use as a
partial vertebral body replacement
in the thoraco-lumbar spine (from
TI to L5) and is intended for use
with supplemental internal fixation.
The ROI may be implanted
sinularly or in pairs. Supplemental
fixation is required to properly
utilize this system | Same as ROI | Indicated for use to replace a vertebral
body that has been resected or excised
due to tumor or trauma/fracture. The
device is intended for use as a
vertebral body replacement in the
thoracolumbar spine (from TI to L5)
and is intended for use with
supplemental internal fixation. | YES |
| Design: | Modular Cage | Cage | Same as CAS SSS | YES |
| Supplied
Sterile: | Yes - Gamma radiation | Yes | Yes - Gamma radiation | YES |
| Material: | PEEK w/ tantalum markers | Titanium | PEEK w/ titanium markers | YES |
| Instruments: | Specialized reusable instruments are
required. Instruments must be
cleaned and sterilized prior to 1st use
and each subsequent use. | Same | Same | YES |
| How used: | Singularly or in pairs | Same | Singularly | YES |
| K Number: | K043349 (under review) | K042268 | K031757 - K041888 | YES |
| Manufacturer: | LDR Medical | EBI | Signus Medizintechnik, Gmbh | YES |
| Product Code: | MOP | MOP | MOP | YES |

• Summary Comparison Table: 11.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized eagle with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian Burkinshaw Director, Innovation and Technology Solutions

LDR Spine USA Incorporated 4030 West Braker Lane, Suite 360

Austin, Texas 78759

Re: K043349 Trade/Device Name: Radiotransparent Open Implant (ROI)- Partial Vertebral Body Replacement (PVBR) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 9, 2005 Received: June 10, 2005

Dear Mr. Burkinshaw:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

JUN 2 9 2005

4

Page 2 – Mr. Brian Burkinshaw

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Rhodes

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

643349

Page 1 of 1

K043349 510(k) Number:

Radiotransparent Open Implant (ROI) – Partial Vertebral Body Device Name(s): Replacement (PVBR)

Indications for Use:

The ROI is indicated for use to replace a vertebral body that has been resected or The KOr is included for as to replace is intended for use as a excised due to tunnor of thatha inche thoracolumbar spine (from TV to LS) and partial vertebrar oddy replacemental internal fixation. The ROI may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Over-The-Counter Use OR × Prescription Use_ PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IN NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rhodes

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

KOY3349 510(k) Number_

(Per 21 CFR 801.109)

(Optional format 1-2-96)

.

P. 1 ot 1