(114 days)
The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skeletally mature patients at one or two contiguous levels of the sacro-lumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via an anterior, posterior or lateral approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The ostaPek Interbody Fusion Cages system consists of four families of cages used with four surgical approaches: the Erriva® ELIF/TLIF Cage (Extraforaminal Lumbar Interbody Fusion/ Transforaminal Lumbar Interbody Fusion), the Gemitra® TLIF Cage, the PLIF Cage (Posterior Lumbar Interbody Fusion) and PLIF Bullet Cage, and the ALIF Cage (Anterior Lumbar Interbody Fusion). All device configurations are available in multiple sizes to adequately fit patient anatomical variations. They all have bone graft windows, ridges or teeth to resist migration, and x-ray markers.
This document is a 510(k) Premarket Notification for a medical device called "ostaPek Interbody Fusion Cages." It is not a document about an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.
The document indicates that the device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, and explicitly states: "No clinical studies were performed."
The request asks for details specific to the evaluation of an AI/ML medical device, which are not applicable to the traditional medical device clearance process described in this document.
Therefore, I cannot provide the requested information based on the provided text.
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November 14, 2018
coLigne, AG % J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K181963
Trade/Device Name: ostaPek Interbody Fusion Cages Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 19, 2018 Received: October 22, 2018
Dear Mr. Webb:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181963
Device Name ostaPek Interbody Fusion Cages
Indications for Use (Describe)
The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral body fusion device in skettally mature patients at one or two contiguous levels of the sacrolumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD) defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed via an anterior, posterior or lateral approach using autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The ostaPek Interbody Fusion Cages are to be used with supplemental fixation cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: ostaPek Interbody Fusion Cages
| Date Prepared | October 16, 2018 |
|---|---|
| Submitted By | Coligne, AGUtoquai 43Zurich, SWITZERLAND 8008email: Robert.Lange@coligne.com |
| Primary Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net |
| Trade Name | ostaPek Interbody Fusion Cages |
| Common Name | Intervertebral Body Fusion Device |
| Classification Name | Intervertebral Body Fusion Device with Bone Graft, Lumbar |
| Class | II |
| Product Code | MAX |
| CFR Section | 21 CFR section 888.3080 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | Brantigan I/F Cage, DePuy Spine (P960025) |
| Secondary PredicateDevices | Lumbar Interbody Fusion Cage System, L&K Biomed (K110783/K151140)BAK Interbody Fusion System, Zimmer Spine (P950002) |
| Reference PredicateDevices | Ray Threaded Lumbar Fusion Cage, Stryker (P950019)Talos PLIF, MediTech (K090707)ACIF implants, Coligne AG (K173148)ostaPek® VBR System, Coligne AG (K072326) |
| Device Description | The ostaPek Interbody Fusion Cages system consists of four families of cages used withfour surgical approaches: the Erriva® ELIF/TLIF Cage (Extraforaminal Lumbar InterbodyFusion/ Transforaminal Lumbar Interbody Fusion), the Gemitra® TLIF Cage, the PLIFCage (Posterior Lumbar Interbody Fusion) and PLIF Bullet Cage, and the ALIF Cage(Anterior Lumbar Interbody Fusion).All device configurations are available in multiple sizes to adequately fit patient anatomicalvariations. They all have bone graft windows, ridges or teeth to resist migration, and x-raymarkers. |
| Materials | Poly-ether-ketone-ether-ketone-ketone (PEKEKK) resin (ASTM F1876)Carbon fiber filamentsGold (ASTM B562) |
| Intended Use | The ostaPek Interbody Fusion Cages system is used to maintain disc space distractionand structural stability until fusion occurs in skeletally mature adults requiring lumbarinterbody fusion. |
| SubstantialEquivalence Claimedto Predicate Devices | The ostaPek Interbody Fusion Cages are substantially equivalent to the predicate devicesin terms of intended use, design, materials used, mechanical safety and performances. |
| Indications for Use | The ostaPek Interbody Fusion Cages system is indicated for use as an intervertebral bodyfusion device in skeletally mature patients at one or two contiguous levels of the sacro-lumbar spine (L2-S1) to facilitate fusion in case of degenerative disc disease (DDD)defined as discogenic pain with degeneration of the disc confirmed by patient history andradiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis orretrolisthesis at the involved level(s). The ostaPek Interbody Fusion Cages are placed viaan anterior, posterior or lateral approach using autogenous bone graft and/or allograftcomprised of cancellous and/or corticocancellous bone graft. The ostaPek InterbodyFusion Cages are to be used with supplemental fixation cleared by the FDA for use in thelumbar spine. Patients should have at least six months of non-operative treatment priorto surgery. Patients with previous non-fusion spinal surgery at involved level may betreated with the device. |
| Summary of thetechnologicalcharacteristicscompared topredicate | Intended UseThe ostaPek Interbody Fusion Cages and all the predicates have similar intended uses.MaterialsThe ostaPek Interbody Fusion Cages are fabricated of the same material as the predicatedevice.Design Features/FunctionsThe ostaPek Interbody Fusion Cages and cited predicate devices share similar basicdesign features and functions.DimensionsThe ostaPek Interbody Fusion Cages system is dimensionally similar to cited predicatedevices.SterilizationThe ostaPek Interbody Fusion Cages system is provided non-sterile and cited predicatedevices are non-sterile for single use only.Performance SpecificationMechanical testing confirmed the ostaPek Interbody Fusion Cages system demonstratedequivalent performance to the cited predicate device under the same test conditions. |
| Non-clinical TestSummary | The following analyses were conducted:● Static and dynamic compression (ASTM F2077)● Subsidence (ASTM F2267)● ExpulsionThe results of these evaluations indicate that the ostaPek Interbody Fusion Cages systemis equivalent to predicate devices. |
| Clinical TestSummary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Coligne AG considers the ostaPek Interbody Fusion Cages system to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices' similarities inprinciples of operation, technology, materials and indications for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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§ 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.