(118 days)
Not Found
No
The summary describes a physical interbody fusion device made of PEEK and tantalum markers, along with associated surgical instruments. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are mechanical tests of the physical device.
Yes
The device is used to facilitate fusion in skeletally mature patients with degenerative disc disease of the cervical spine, which is a therapeutic intervention.
No
This device is described as an intervertebral body fusion device used for treatment, not for diagnosing medical conditions.
No
The device description explicitly states the system is comprised of physical components made of PEEK and tantalum, and is implanted using stainless steel instruments. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a cervical intervertebral body fusion device used for surgical implantation in patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a physical implant made of PEEK and tantalum markers, designed to be surgically placed. This is consistent with a medical device for implantation, not a diagnostic reagent or instrument used to analyze biological samples.
- No mention of biological samples or analysis: The document does not mention the collection or analysis of any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Performance Studies: The performance studies described are mechanical tests (compression, torsion, subsidence, expulsion) on the device itself, not studies evaluating its ability to diagnose a condition based on biological markers.
In summary, the Maxim Surgical X-Treme Interbody Fusion System is a surgically implanted medical device for treating a spinal condition, not a device used to diagnose a condition by testing samples outside the body.
N/A
Intended Use / Indications for Use
When used as a cervical intervertebral body fusion device, the Maxim Surgical X-Treme Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Maxim Surgical X-Treme Interbody Fusion System is a cervical interbody fusion system comprised of neutral and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
The Maxim Surgical X-Treme Interbody Fusion System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The Maxim Surgical X-Treme Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, one disc level from the C2-C3 disc to the C7-T1 disc
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 following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-11
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11
- Subsidence testing, conducted in accordance with ASTM F2267-04
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02
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.
P980048, K043479, K091088, K090064, K110733
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.
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K123206 Page 1 of 2
FEB 0 7 2013
510(k) Summary Maxim Surgical X-Treme Interbody Fusion System Premarket Notification
SUBMITTED BY
ﺮ
Maxim Surgical 1565 North Central Expressway, Suite 200 Richardson, Texas 75080
ESTABLISHMENT REGISTRATION NUMBER
Pending
OWNER/OPERATOR NUMBER
Pending
CONTACT PERSON
Chris Reeg President Maxim Surgical Phone: 214-564-1350 Fax: 972-692-8934
SUBMISSION PREPARED BY
Lisa Peterson Kaedon Consulting, LLC Phone: 512-507-0746
Intervertebral Body Fusion Device
888.3080 (Product Code ODP)
DATE PREPARED
January 9, 2013
CLASSIFICATION NAME
DEVICE CLASS
Class II
REGULATION NUMBER
COMMON NAME
PROPRIETARY NAME
IDENTIFICATION OF PREDICATE DEVICE(S)
Intervertebral Fusion Device with Bone Graft, Cervical
Maxim Surgical X-Treme Interbody Fusion System
Predicate devices include various cleared interbody fusion systems:
- -Zimmer Spine: BAK/C (P980048)
- ﻬ LDR Spine: MC+ (K043479, K091088)
- -Eminent Spine: Eminent Spine Interbody Fusion System (K090064)
- -SpineNet, LLC: Daytona Anterior Cervical Cage (K110733)
1
DEVICE DESCRIPTION
The Maxim Surgical X-Treme Interbody Fusion System is a cervical interbody fusion system comprised of neutral and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
The Maxim Surgical X-Treme Interbody Fusion System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The Maxim Surgical X-Treme Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
INDICATIONS
When used as a cervical intervertebral body fusion device, the Maxim Surgical X-Treme Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with decenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-Tl disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograff to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The purpose of this premarket notification is to obtain clearance to market the Maxim Surgical X-Treme Interbody Fusion System. The Maxim Surgical X-Treme Interbody Fusion System is comprised of neutral and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.
The Maxim Surgical X-Treme Interbody Fusion System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:
- Intended for use at one level from the C2-C3 disc to the C7-TI disc for the treatment of degenerative disc disease (DDD) of the cervical spine with accompanying radicular symotoms.
- Substantially equivalent results of non-clinical testing relative to static and dynamic testing -(per ASTM F2077-11 ), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)
DISCUSSION OF NON-CLINICAL TESTING
The following non-clinical tests were conducted:
- Static and dynamic compression testing, conducted in accordance with ASTM F2077-11 י
- Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11 ।
- Subsidence testing, conducted in accordance with ASTM F2267-04 י
- Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02 1
CONCLUSIONS
The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Maxim Surgical X-Treme Interbody Fusion System is substantially equivalent to the predicate device.
2
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 consists of a stylized emblem with three curved lines, resembling a human figure, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the emblem. The emblem is positioned to the right of the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: February 7, 2013
Maxim Surgical % Mr. Chris Reeg President 1565 North Central Expressway, Suite 200 Richardson, TX 75080
Re: K123206
Trade/Device Name: Maxim Surgical X-Treme Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 16, 2013 Received: January 16, 2013
Dear Mr. Reeg:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Chris Reeg
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 yours,
Mark N. Melkerson
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
K123206 510(k) Number (if known):
Maxim Surgical X-Treme Interbody Fusion System Device Name:
Indications for Use:
When used as a cervical intervertebral body fusion device, the Maxim Surgical X-Treme Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stephanie Beghtold -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123206
1565 North Central Expressway, Suite 200 Richardson, Texas 75080