(81 days)
Not Found
No
The summary describes a mechanical spine fixation system and explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The Expedium Spine System (a spine implant) is used for fixation and stabilization of the spine, which is a supportive and corrective function rather than one that treats or cures a disease or condition.
No
This device is a surgical system (Expedium™ Spine System) intended for spinal fixation, not for diagnosing medical conditions. Its descriptions focus on physical components and intended surgical uses.
No
The device description explicitly states it includes physical components like rods, surgical instruments, and cases, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for spinal fixation in patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details surgical components like rods and instruments, which are used directly in a surgical procedure on a patient.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on such analysis. IVDs are designed to perform tests on these types of samples.
The Expedium Spine System is a medical device used for surgical treatment, not for diagnosing a disease or condition.
N/A
Intended Use / Indications for Use
The Expedium Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Product codes
KWP, MNH, MNI, NKB, KWQ
Device Description
Expedium Spine System components are designed to accept a 5.5mm rod and are available in various geometries and sizes. The Expedium Spine System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical
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)
Performance data were submitted to characterize the additonal Expedium Spine System components.
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
| IX. 510(k) Summary | K041119 | JUL 1 9 2004 |
|---|---|---|
| SUBMITTER: | DePuy Spine, Inc. | |
| 325 Paramount Drive | ||
| Raynham, MA 02780 | ||
| CONTACT PERSON: | Jennifer Mooney | |
| DATE PREPARED: | April 26, 2004 | |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal | |
| Orthosis, Spinal Pedicle Fixation, Spinal Intervertebral | ||
| Body Fixation | ||
| PROPRIETARY NAME: | Expedium Spine System | |
| PREDICATE DEVICES: | Expedium Spine System (Merlin Spine System) | |
| K033901 | ||
| DEVICE DESCRIPTION: | Expedium Spine System components are designed to | |
| accept a 5.5mm rod and are available in various | ||
| geometries and sizes. |
The Expedium Spine System also contains Class 1
manual surgical instruments and cases that are
considered exempt from premarket notification | |
| INTENDED USE: | The Expedium Spine System is intended for
noncervical pedicle fixation and nonpedicle fixation for
the following indications: degenerative disc disease
(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; curvatures
(i.e., scoliosis, kyphosis, and/or lordosis); tumor;
pseudoarthrosis; and failed previous fusion in
skeletally mature patients. | |
| MATERIALS: | Manufactured from ASTM F-138 and F-1314 implant
grade stainless steel and ASTM F-136 implant grade
titanium alloy. | |
| PERFORMANCE
DATA: | Performance data were submitted to characterize the
additonal Expedium Spine System components. | |
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a symbol that looks like three stylized human figures connected at the shoulders. The symbol is black and the background is white.
Public Health Service
JUL 1 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K04119
Trade/Device Name: Expedium Spine System Regulation Number: 21 CFR 888.3050; 21 CFR 888.3060; 21 CFR 888.3070 Regulation Name: Spinal interlaminar fixation orthosis, Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: II Product Code: KWP, MNH, MNI, NKB, KWQ Dated: June 25, 2004 Received: June 28, 2004
Dear Ms. Starowicz:
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.
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
2
Page 2 - Ms. Sharon Starowicz
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (301) 594-4659. 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 Manufacturers, International and Consumer 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,
Celia 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 lll.
04/119 510(k) Number (if known): J
Expedium™ Spine System Device Name:
Indications For Use:
The Expedium™ Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 8C7 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office ral. Restorative, and Neurological Devices DePuy Spine, Inc. Page 5 Special 510K