(68 days)
Not Found
No
The device description and intended use are for a mechanical spinal fixation system and associated manual instruments, with no mention of software, algorithms, or AI/ML capabilities.
No
The Expedium MIS Spine System is a surgical implant (pedicle screws and rods) used for fixation in spinal conditions, not a device that provides therapy itself.
No
The device description clearly states it is a "Spine System" consisting of "pedicle screws and 5.5mm rods" and "Class 1 manual surgical instruments". This indicates it is an implant and surgical tool, designed for treatment (fixation, fusion) of spinal conditions, not for diagnosing them. The indications for use list various spinal conditions that the system is intended to treat.
No
The device description explicitly states it consists of cannulated polyaxial pedicle screws, rods, and manual surgical instruments, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical system for spinal fixation in skeletally mature patients with various spinal conditions. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device consists of surgical implants (screws and rods) and manual surgical instruments. These are used in the body during surgery, not on samples taken from the body for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Expedium MIS Spine System is clearly a surgical implant system used for treatment.
N/A
Intended Use / Indications for Use
The Expedium MIS 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.
When used in a percutaneous, posterior approach with MIS instrumentation, the Expedium MIS System screw components are 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
NKB, MNI, MNH, KWP, KWQ
Device Description
The Expedium MIS System consists of cannulated polyaxial pedicle screws and 5.5mm rods in various lenaths. The Expedium MIS System also contains Class 1 manual surgical instruments to aid in the percutaneous approach, 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
Spinal, 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 notched rod with the cannulated polyaxial screws.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
SEP - 8 2004
- X. 510(k) Summary
K0411801
page 1 of 2
| SUBMITTER: | DePuy Spine, Inc. |
|---|---|
| 325 Paramount Drive | |
| Raynham, MA 02780 |
Jennifer Mooney CONTACT PERSON:
June 30, 2004 DATE PREPARED:
CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation
Expedium™ MIS Spine System PROPRIETARY NAME:
Expedium™ Spine System (K033901), CD Horizon® PREDICATE DEVICES: Spinal System (K032033 and K032265)
The Expedium MIS System consists of cannulated DEVICE DESCRIPTION: polyaxial pedicle screws and 5.5mm rods in various lenaths.
The Expedium MIS System also contains Class 1 manual surgical instruments to aid in the percutaneous approach, and cases that are considered exempt from premarket notification.
The Expedium MIS Spine System is intended for INTENDED USE: 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.
When used in a percutaneous, posterior approach with MIS instrumentation, the Expedium MIS System screw components are 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
1
K041801
page 2 of 2
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.
Manufactured from ASTM F-136 implant grade MATERIALS: titanium alloy.
PERFORMANCE Performance data were submitted to characterize the DATA: notched rod with the cannulated polyaxial screws.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 8 2004
Ms. Jennifer Mooney Regulatory Affairs Associate Depuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K041801
Trade/Device Name: Expedium™ MIS Spine System Frace/Doviet Number: 21 CFR 888.3070, 21 CFR 888.3050, 21 CFR 888.3060 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: July 1, 2004 Received: July 2, 2004
Dear Ms. Mooney:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 for use stated in the encreation of the enactment date of the Medical Device Amendments, or to conniner or prior to may 20, 2011 - 11:11 accordance with the provisions of the Federal Food, Drug, de neces that have been require approval of a premarket approval application (PMA). and Cosmetter For (110) that as asvice, subject to the general controls provisions of the Act. The Tournaly, therefore, maines of the Act include requirements for annual registration, listing of general controls pro ractice, 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 If your device is elassified (600 as controls. Existing major regulations affecting your device can may or sabject to back areas 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 that I Dr Hab Intact a and regulations administered by other Federal agencies. You must or any I odolar statutes and states and station but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 – Ms. Jennifer Mooney
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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) This letter will anow you to begin mailioning of substantial equivalence of your device to a legally premits that in the PDA mians of cation 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 If you desire specific advice for Jour as 1) 594-4692. Also, please note the regulation entitled, p Colliact the Office of Companies market notification" (21CFR Part 807.97). You may obtain Misolanding by reference to promanton in the Act from the Division of Small other general 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,
Mark N. Milliken
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use IV.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Expedium MIS Spine System Device Name:
Indications For Use:
The Expedium MIS Spine System is intended for noncervical The Expedium MIO Opine Oyetting for the following indications: pedicle fixation and nomported as back pain of discogenic degenerative also discuss of the disc confirmed by history and ongin with degenoration of en of clickly trauma (i.e., fracture or radiographio studios); spen: ; curvatures (i.e., scoliosis, kyphosis, ulsiocation); Spinal Stonocio; Jan thereosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS Instrumentation, the Expedium MIS System screw components are intentation, the Expodian Mis Uyearam Mis Uynand nonpedicle fixation for interior for nonomations: degenerative disc disease (defined as the following manogenic origin with degeneration of the disc back pain of diosege and radiographic studies); spondylolisthesis; conlinned by nietery arr dislocation); spinal stenosis; curvatures tradina (i.o., maolaro of alend/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Mark N. Milkeron
Division of General, Restorative, and Neurological Devices
510(k) Number K041801
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use: _____________________________________________________________________________________________________________________________________________________ Prescription Use: _ (Per 21 CFR 801.109)