(75 days)
Not Found
No
The summary describes a mechanical spine fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for noncervical pedicle and nonpedicle fixation for various spinal conditions, directly treating or alleviating these conditions.
No
Explanation: The device description states it is a "Spine System" used for "pedicle fixation and nonpedicle fixation" in various spinal conditions, and includes "manual surgical instruments." This indicates it is an implantable or surgical device, not a device used to diagnose a medical condition.
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 for spinal fixation. This is a device used in vivo (within the body) to treat structural issues of the spine.
- Device Description: The description talks about rods, components, surgical instruments, and cases, all of which are consistent with a surgical implant system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to diagnose diseases or conditions in vitro (outside the body).
This device is a surgical implant, not an in vitro diagnostic device.
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
NKB, MNI, MNH, KWP
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
Spine (noncervical pedicle fixation and nonpedicle fixation)
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 additional 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
§ 888.3070 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.
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Page 1 of 1
| IX. | 510(k) Summary | K051024 |
|---|---|---|
| SUBMITTER: | JUL 6 - 2005 | |
| DePuy Spine, Inc. | ||
| 325 Paramount Drive | ||
| Raynham, MA 02780 | ||
| CONTACT PERSON: | Mary E. Gray | |
| DATE PREPARED: | April 21, 2005 | |
| 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 and Expedium Spine System K041119 | ||
| 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 implant grade
stainless steel and ASTM F-136 implant grade
titanium alloy. |
| | PERFORMANCE
DATA: | Performance data were submitted to characterize the
additional Expedium Spine System components. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 6 - 2005
Mary E. Gray, RAC DePuy Spine, Inc. Sr. Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K051024
Trade/Device Name: Expedium™ Spine System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedical screw spinal system, Spinal interlaminal fixation orthosis Regulatory Class: III Product Code: NKB, MNI, MNH, KWP Dated: June 3, 2005 Received: June 6, 2005
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becare in ad 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 entress. 1976, the enactment date of the Medical Device Amendments, or to commerce pror to this) 2005 reclassified in accordance with the provisions of the Federal Food, Drug, de nees mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, mererore, mains 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 rr your device to such additional controls. Existing major regulations affecting your device can may or subject to been and 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 r rouse of activer him is to revice complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I 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 - Mary E. Gray, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to organ maining of substantial equivalence of your device to a legally prematication: The PDF interessification 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 doon't bpoorne at (240) 276-_. Also, please note the regulation entitled, Connact the Office of Course 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 informational 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/industry/support/index.html.
Sincerely yours,
Stupt Clurle
Dr. Michael C. Rivera, Ph.D.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
lll. Indications for Use
| 510(k) Number (if known): | K051024 |
|---|---|
| --------------------------- | --------- |
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 _____________________________________________________________________________________________________________________________________________________________ × (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)
Styph Curda
Division of General, Restorative,
DePuy Spine, Inc. Special 510K
and Neurologic
Page 5
510(k) Number K051024