(153 days)
P970015, P950002, P950019, P960025
No
The description focuses on the physical characteristics and intended use of a spinal implant, with no mention of AI or ML.
Yes
The device is a spinal implant intended to treat degenerative disc disease and provide stability, which are therapeutic functions.
No
This device is an implantable spinal system (interbody fusion device) designed to treat degenerative disc disease by providing structural support and holding bone graft material, not for diagnosing medical conditions.
No
The device description clearly states it is a "Spinal System" consisting of "hollow vertebral body spacers" made of PEEK, which are physical implants. This is a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The CAPSTONE® Spinal System is a physical implant designed to be surgically placed in the lumbar spine to fuse vertebrae. It is a structural device, not a diagnostic test.
- Intended Use: The intended use is to treat degenerative disc disease by providing support and promoting bone fusion. This is a therapeutic intervention, not a diagnostic process.
The provided information clearly describes a surgical implant used for spinal fusion, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The CAPSTONE® PEEK Spinal System consists of a variety of hollow vertebral body spacers featuring a convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is made of various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 16mm in height and from 22mm to 36mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
skeletally mature
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)
Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject CAPSTONE® Spinal System is substantially equivalent to five recently down classified interbody cages, the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120, Innovative Spinal Technologies, SE 10/11/07).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120)
Reference Device(s)
LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015), BAK® Cage (P950002), RAY® Threaded Fusion Cage (P950019), Lumbar I/F Cage (P960025)
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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CAPSTONE® Spinal System 510(k) Summary - K073291 April 2008
APR 2 4 2008
- Medtronic Sofamor Danek l. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Contact: Lee Grant Senior Project Specialist, Regulatory Affairs
Proprietary Trade Name: CAPSTONE® Spinal System II.
Classification Name: Intervertebral Body Fusion Device (21 CFR 888.3080) III.
IV. Product Code: MAX
Product Description V.
The CAPSTONE® PEEK Spinal System consists of a variety of hollow vertebral body spacers featuring a convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is made of various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 16mm in height and from 22mm to 36mm in length.
V. Indications
The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
1
73291
VI. Substantial Equivalence
Documentation, including mechanical test results and published literature, was provided which demonstrated that the subject CAPSTONE® Spinal System is substantially equivalent to five recently down classified interbody cages, the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120, Innovative Spinal Technologies, SE 10/11/07).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek USA % Mr. Lee Grant Senior Project Specialist, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132
APR 2 4 2008
Re: K073291
Trade/Device Name: CAPSTONE® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: April 11, 2008 Received: April 14, 2008
Dear Mr. Grant:
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 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.
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Page 2 - Mr. Lee Grant
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K073291
Device Name: CAPSTONE® Spinal System
Indications for Use:
The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Prescription Use ਮ (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)
Net R.P. Ogle formxn
(Division Sign-Off)
Division of General, Restorative. and Neurological Devices
510(k) Number K073291