(147 days)
No
The document describes a physical intervertebral body fusion device and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used for intervertebral body fusion procedures to treat degenerative disc disease, which involves repairing a damaged or diseased part of the body.
No
Explanation: The device, IMPIX DLIF Lumbar Interbody Device, is an implantable medical device used for intervertebral body fusion procedures. Its purpose is to treat degenerative disc disease by fusing vertebrae, not to diagnose a condition. The description focuses on its physical characteristics, material, and mechanical testing, which are all related to its function as a therapeutic implant.
No
The device description clearly states it is a "Lumbar Interbody device" made of "PEEK OPTIMA® LT1" and describes its physical shape and features, indicating it is a physical implant, not software.
No, 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 and Intended Use: The provided text clearly describes a surgical implant (a lumbar interbody device) used to facilitate bone fusion in the spine. It is physically implanted into the patient's body during a surgical procedure.
- Lack of Diagnostic Activity: The device does not perform any tests on biological samples to diagnose or monitor a condition. Its function is mechanical and biological (promoting bone growth).
Therefore, based on the provided information, the IMPIX DLIF Lumbar Interbody Device is a medical device, specifically a surgical implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IMPIX DLIF Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondvlolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX DLIF Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Product codes
MAX
Device Description
The purpose of this submission is to submit the new Lumbar Interbody device: IMPIX-DLIF, or Dual Lateral Interbody Fusion, has a rectangular shape with a front beveled and has three areas inside for use with autogenous bone graft.
This new device and IMPIX-L Interbody devices previously cleared in K072226 are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ in geometry and approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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
Non-clinical Test Summary:
Testing was performed on the IMPIX DLF following the protocols outlined in ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression".
The following tests were conducted:
- . Static axial Compression results
- . Static compression-shear results
- . Static torsion results
- Static subsidence results
Clinical Test Summary:
No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
K072226, K072797, K073177, K080822
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/2 description: The image shows the word "MEDICREA" in bold, black letters. The letters are capitalized and have a slightly blocky appearance. To the left of the word is a small, abstract graphic that appears to be a stylized representation of a medical symbol. The word and the graphic are enclosed in a rectangular border.
510(k) Summary for the IMPIX DLIF
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the IMPIX DLIF.
Date Prepared: June 14, 2010
-
- Submitter:
MEDICREA TECHNOLOGIES ZI CHEFDE BAIE LA ROCHELLE 17000 FR
- Submitter:
Contact Person:
J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 Telephone: 512-388-0199
Image /page/0/Picture/10 description: The image shows a date stamp that reads "JUL 22 2010". The text is in a bold, sans-serif font. The date is likely indicating when a document was received or processed.
FDA CDRH DMC
-
- Trade name: IMPIX DLIF LUMBAR Interbody Device Common Name: Intervetebral body fusion Classification Name: Intervertebral body fusion device - lumbar
3. Predicate or legally marketed devices which are substantially equivalent:
- The IMPIX-L Lumbar Cages (MEDICREA, K072226) .
- The ORACLE Spacer (Synthes, K072797) .
- . The CROSS-FUSE (Pioneer, K073177)
- . The Vu-a-Pod (Theken spine, K080822)
Description of the device: র্ব
The purpose of this submission is to submit the new Lumbar Interbody device: IMPIX-DLIF, or Dual Lateral Interbody Fusion, has a rectangular shape with a front beveled and has three areas inside for use with autogenous bone graft.
This new device and IMPIX-L Interbody devices previously cleared in K072226 are manufactured in the same material, PEEK OPTIMA® LT1, and have the same Indications for use. The devices differ in geometry and approach.
Materials: PEEK OPTIMA LT1
Function: The IMPIX DLIF was developed as an implant:
- . to maintain and/or to restore the intervertebral height and the spinal curve (after discectomy)
- . to promote bone fusion
- to provide stability to ease fusion �
- . to be mechanically resistant to allow the fusion of the operated level
5. Substantial equivalence claimed to predicate devices
IMPIX DLIF is substantially equivalent to the IMPIX-L in terms of intended use, materials used, mechanical safety and performances, and the ORACLE Spacer or the Cross-Fuse in terms of intended use, design, materials used, mechanical safety and performances. IMPIX DLIF 40mm is substantially equivalent to the Vu-a-Pod for an antero-lateral approach.
The table below compares the features and characteristics of the IMPIX DLIF to these predicate devices.
| Device | IMPIX DLIF | IMPIX-L
Interbody Device
(MEDICREA) | ORACLE Spacer
(SYNTHES) | Vu-a-Pod
(Theken Spine) | CROSS-FUSE
(Pioneer) |
|------------------|------------|-------------------------------------------|----------------------------|----------------------------|-------------------------|
| 510(k)
number | / | K072226 | K072791 | K080822 | K073177 |
| Intended use | | | | | |
1
Image /page/1/Picture/2 description: The image shows the word "MEDICREA" in bold, black letters. To the left of the word is a small, abstract graphic. The letters are evenly spaced and appear to be part of a logo or brand name. The background is white.
| Device | IMPIX DLIF | IMPIX-L
Interbody Device
(MEDICREA) | ORACLE Spacer
(SYNTHES) | Vu-a-Pod
(Theken Spine) | CROSS-FUSE
(Pioneer) |
|---------------------------|------------------------------------------|-------------------------------------------|----------------------------------|---------------------------------------------|----------------------------------|
| Lumbar spine | Yes | Yes, | Yes | Yes | Yes |
| Anterolateral
Approach | Yes, only with
the 40mm DLIF
cages | No | No | Yes | No |
| Lateral
Approach | Yes | No | Yes | No | Yes |
| Design | | | | | |
| Bone
graft
cavity | Yes | Yes | Yes | Yes | Yes |
| Teeth / ridges | Yes | Yes | Yes | Yes | Yes |
| X-Ray Markers | Yes | Yes | Yes | Yes | Yes |
| Shape | Rectangular
shape | Rectangular
shape | Oval shape | Rectangular
shape | Rectangular
shape |
| Materials | | | | | |
| Lumbar cage | PEEK OPTIMA®
LT1 (ASTM
F2026) | PEEK OPTIMA®
LT1 (ASTM F2026) | PEEK OPTIMA®
LT1 (ASTM F2026) | PEEK OPTIMA
LT1 (ASTM
F2026) | PEEK OPTIMA®
LT1 (ASTM F2026) |
| Pins markers | Tantalum (ISO
13782) | Tantalum (ISO
13782) | Tantalum (ISO
13782) | Titanium, Ti-
6Al-4V ELI
(ASTM F-136) | Tantalum (ISO
13782) |
દ. Intended Use:
IMPIX DLIF Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondvlolisthesis at the involved level(s). This device is to be used with autogenous bone graft. IMPIX DLIF Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
7. Non-clinical Test Summary:
Testing was performed on the IMPIX DLF following the protocols outlined in ASTM F2077 "Test Methods for Intervertebral Body Fusion Devices" and ASTM F2267 "Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression".
The following tests were conducted:
- . Static axial Compression results
- . Static compression-shear results
- . Static torsion results
- Static subsidence results ●
8. Clinical Test Summary
No clinical studies were performed
ರು Conclusions Nonclinical and Clinical
IMPIX DLF is substantially equivalent to the predicate devices in terms of indications for use, design, material and function.
2
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 eagle with three lines forming its body and head. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medicrea Technologies % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K100544
Trade/Device Name: IMPIX® DLIF Lumbar Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 18, 2010 Received: June 22, 2010
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. 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
IJUL 2 2 2010
3
Page 2 - Mr. J.D. Webb
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); 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 yours,
Bartare meins
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K100544 Device Name: IMPIX® DLIF Indications for Use:
IMPIX DLIF Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft.
IMPIX DLIF Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (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 801 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-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI00544 510(k) Number