(102 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is described as an "Anterior Spine System" intended for fixation purposes to treat various spinal conditions such as degenerative disc disease, spondylolisthesis, trauma, and deformities, which directly addresses disease or injury.
No
The device description and intended use indicate it is an implantable system (spinal rods, screws, staples, washers, and cross connectors) used for stabilization and fixation of the spine, not for diagnosing conditions.
No
The device description explicitly lists physical components (spinal rods, screws, staples, washers, cross connectors) made of titanium alloy, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Expedium Anterior Spine System: This device is an implantable system (rods, screws, staples, etc.) used for surgical fixation of the spine. It is used within the body during a surgical procedure to treat various spinal conditions.
The description clearly indicates a surgical implant for structural support and fixation within the spine, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Expedium™ Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium™ Anterior Spine System may be used in either thoracoscopic procedures or open procedures.
The Expedium Anterior Spine System is indicated for:
- degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- spinal stenosis
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- tumor
- pseudarthrosis
- previous failed fusion
Product codes
KWQ
Device Description
The Expedium Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The implants of the Expedium Anterior Spine System have been designed for use in either open or thoracoscopic approaches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T4 to L4 levels of the spine
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)
Performance data were submitted to characterize the
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
AUG 1 7 2004
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X. 510(k) Summary
K04/1205
page 1 of 1 -
DePuy Spine, Inc. SUBMITTER: 325 Paramount Drive Raynham, MA 02780
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CONTACT PERSON: Jennifer Mooney
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DATE PREPARED: April 29, 2004
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Spinal Intervertebral Body Fixation Orthosis CLASSIFICATION NAME:
-
Expedium™ Anterior Spine System PROPRIETARY NAME:
-
Frontier Anterior Scoliosis System (K012916) PREDICATE DEVICES:
-
DEVICE DESCRIPTION: The Expedium Anterior Spine System consists of spinal rods, monoaxial screws, staples, washers, and cross connectors. The implants of the Expedium Anterior Spine System have been designed for use in either open or thoracoscopic approaches.
-
The Expedium Anterior Spine System is intended for anterolateral screw INTENDED USE: fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The Expedium Anterior Spine System may be used in either thoracoscopic procedures or open procedures.
The Expedium Anterior Spine System is indicated for:
- degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
-
- spondylolisthesis
-
- trauma (i.e., fracture or distocation)
-
- spinal stenosis
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
-
- tumor
-
- pseudarthrosis
-
- previous failed fusion
Manufactured from ASTM F-136 implant grade titanium MATERIALS: allov. PERFORMANCE DATA: Performance data were submitted to characterize the
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2004
Jennifer Mooney Regulatory Affairs Associate DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K041205
Trade/Device Name: Expedium™ Anterior Spine System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: August 4, 2004 Received: August 5, 2004
Dear Ms. Mooney:
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). and Ooomether fore, 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 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.
2
Page 2 - Jennifer Mooney
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your he FDA finding of substantial equivalence of your device to a legally premated 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 rryou desire specific as not any and (301) 594-4692. 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 other general information on Jour Corpomer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Stip A. Rhodes
Celia M. Witten, Ph.D., M.D.
elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use IV.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Expedium™ Anterior Spine System Device Name:
Indications For Use:
The Expedium™ Anterior Spine System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The T = to = Hoven of the System may be used in either thoracoscopic procedures or open procedures.
The Expedium Anterior Spine System is indicated for:
- degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
-
- spondylolisthesis
-
- trauma (i.e., fracture or dislocation)
-
- spinal stenosis
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
-
- tumor
-
- pseudarthrosis
-
- previous failed fusion
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS I.INE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| -- | -------------------------------------------- |
| 510(k) Number | K041205 |
|---|---|
| --------------- | --------- |
| DePuy Spine, Inc. | Page 7 |
|---|---|
| 510K |