ORIO Cervical Intervertebral Body Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. ORIO Cervical Intervertebral Body Fusion Cages used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. ORIO Cervical Intervertebral Body Fusion Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The ORIO Lumbar Intervertebral Body Fusion Cage 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. Degeneralive 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 at the involved level(s). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO Lumbar Intervertebral Body Fusion Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The ORIO Intervertebral Body Fusion Cages were developed as implants for the stabilization of the lumbar spinal column and anterior cervical spondylodesis. The ORIO implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ORIO Intervertebral Body Fusion Cages, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Mechanical Strength	Meets required mechanical strengths as per ASTM F2077/F2267 standards.	The ORIO Intervertebral Body Fusion Cages meet required mechanical strengths.	Non-clinical Tests
Material Compatibility	Uses PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications).	The device is made of PEEK-OPTIMA LT1 polymer (ASTM F2026).	Material Specification
Indications for Use (Cervical)	Skeletally mature patients with DDD of the cervical spine with accompanying radicular symptoms at one disc level (C3-C7), defined by discogenic pain and radiographic studies, for anterior approach with autograft bone and supplemental fixation; at least 6 weeks of non-operative treatment prior.	The device's indications match this criterion.	Review of Indications
Indications for Use (Lumbar)	Skeletally mature patients with DDD of the lumbar spine at one or two contiguous levels from L2-S1, defined by discogenic back pain and radiographic studies; may have up to Grade 1 spondylolisthesis or retrolisthesis; used with autogenous bone graft and implanted via transforaminal, open posterior, anterior/anterolateral, or lateral approach, with supplemental fixation; at least 6 months of non-operative treatment prior.	The device's indications match this criterion.	Review of Indications

2. Sample Size Used for the Test Set and Data Provenance:

The provided text does not describe human clinical trials or a specific "test set" in the context of typical medical device performance evaluation (e.g., diagnostic accuracy, clinical outcomes). The evaluation primarily focuses on non-clinical mechanical testing and comparison to predicate devices.

Test Set Sample Size: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of devices tested, which is not specified in the document beyond a general statement that "tests indicate the... cages meet required mechanical strengths."
Data Provenance: Not applicable for human data. The non-clinical tests are presumed to be conducted in a laboratory setting. There is no mention of country of origin or whether the data is retrospective or prospective for any human studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not provided in the document. The evaluation relies on standardized mechanical testing against ASTM standards and a comparison of design and materials to previously cleared devices. Expert consensus for "ground truth" as typically understood in AI or clinical studies is not relevant here.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable given the nature of the evaluation (non-clinical mechanical testing and comparison to predicate devices).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document does not mention any MRMC comparative effectiveness study. This type of study would typically assess the impact of AI on human reader performance, which is not relevant for an intervertebral body fusion cage.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not applicable. The device is a physical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this submission.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on:

Standardized Mechanical Testing: Adherence to established ASTM standards (F2077/F2267) for mechanical strength. The standards themselves define the "ground truth" for acceptable performance.
Material Specifications: Adherence to ASTM F2026 for the PEEK material.
Predicate Device Equivalence: The primary basis for clearance is demonstrating "substantial equivalence" to previously cleared devices by having "the same indications and material, and similar designs." The "ground truth" for this is the historical clearance of those predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an implanted medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set for this device.

Summary

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K040887

510(k) Summary for the ORIO Intervertebral Body Fusion Cages

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the ORIO Intervertebral Body Fusion Cages.

Date Prepared: March 24, 2009

1.	Submitter:SpineCraft LLC2215 Enterprise DriveWestchester, IL 60154	Contact Person:J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199	OCT 3 0 2005
2.	Trade name:	- ORIO-C Intervertebral Body Fusion Cervical Cage- ORIO-PL PLIF Intervertebral Body Fusion Lumbar Cage- ORIO-TL TLIF Intervertebral Body Fusion Lumbar Cage- ORIO-AL ALIF Anterior/Anterolateral Intervertebral Body FusionLumbar Cage
	Common Name:Classification Name:	intervertebral body fusion deviceintervertebral body fusion device - cervicalIntervertebral body fusion device - lumbar21 CFR section 888.3080ODP/MAXClass II

Predicate or legally marketed devices which are substantially equivalent: 3.

ORIO Intervertebral Body Fusion Cages are substantially equivalent to similar previously cleared cervical and lumbar intervertebral body fusion devices.

Description of the device: ব

Materials:

PEEK-OPTIMA LT1 polymer (ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications)

Intended Use: ട.

Page 1 of 2

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K090887

level(s). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO Lumbar Intervertebral Body Fusion Cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Comparison of the technological characteristics of the device to predicate and legally 6. marketed devices:

The ORIO Intervertebral Body Fusion Cages have the same indications and material, and similar designs as previously cleared devices.

7. Summary of Non-clinical Tests

mary of Not of Not of Not F2077/F2267 indicate that the ORIO Intervertebral Body Fusion Cages meet required mechanical strengths. Some of the predicate devices have a different geometry than the ORIO Intervertebral Body Fusion Cages and do not have some test results reported in their PMA and 510 (k) summaries, therefore, additional acceptance values for testing have been utilized.

Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem of a stylized caduceus, a symbol often associated with medicine and healthcare. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The emblem and text are in a blue color.

DEC 16 2009

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

SpineCraft, LLC % Mr. J.D Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock. Texas 78681

Re: K090887

Trade/Device Name: ORIO-C Intervertebral Body Fusion Cervical Cage ORIO-PL PLIF Intervertebral Body Fusion Lumbar Cage ORIO-TL TLIF Intervertebral Body Fusion Lumbar Cage ORIO-AL ALIF Anterior/Anterolateral Intervertebral Body Fusion Lumbar Cage

Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: October 30, 2009 Received: October 30, 2009

Dear Mr. Webb:

This letter corrects our substantially equivalent letter of October 30. 2009.

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 (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.

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

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Page 2- Mr. J.D. Webb

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 vours.

Sincerely yours,

Mark n millerm

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

Enclosure

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Indications for Use

510(k) Number (if known): _KO90887

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The ORIO lumbar intervertebral body fusion cage 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 spondylolisthesis or retrolisthesis at the involved level(s). ORIO lumbar intervertebral body fusion cage implants are to be used with autogenous bone graft and implanted via a transforaminal, open posterior, anterior/anterolateral or lateral approach. The ORIO lumbar intervertebral body fusion cages are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Off

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

510(k) Number K090887

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Indications for Use

510(k) Number (if known): _KO90887

Device Name: ORIO cervical intervertebral body fusion cages

Indications for Use:

ORIO cervical intervertebral body fusion cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. ORIO cervical intervertebral body fusion cages used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 discliens using autograft bone. ORIO cervical intervertebral body fusion cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K090887 510(k) Number_

Page 2 of 2
ii

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.