(12 days)
Not Found
No
The summary describes a mechanical spinal implant system and associated instruments. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML.
Yes.
The device is intended to treat various spinal disorders and provide stabilization, which describes a therapeutic purpose.
No
The Malibu Spinal System is described as an implantable device (screws, locking caps) and associated instruments designed to correct spinal disorders and provide stabilization for spinal fusion. Its intended use is therapeutic (stabilization, fusion), not diagnostic (identifying or characterizing disease).
No
The device description explicitly details physical components made of titanium alloy, cobalt alloy, and stainless steel, which are hardware implants and instruments, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical implant for correcting spinal disorders and providing stabilization. This is a therapeutic and structural function within the body.
- Device Description: The device description details physical components like screws, caps, and instruments made of materials like titanium alloy, cobalt alloy, and stainless steel. These are typical components of surgical implants and instruments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are used in vitro (outside the body) for diagnostic purposes.
The Malibu Spinal System is a surgical implant and associated instruments, not a diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate devices. The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:
- degencrative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis, .
- trauma (i.e., fracture or dislocation), .
- spinal stenosis. .
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- spinal tumor, .
- pseudoarthrosis, and/or
- failed previous fusion. ●
The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to 71-L5 and are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- . spondylolisthesis
- trauma (i.e., fracture or dislocation), ●
- spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- ◆ tumor,
- pseudarthosis, and/or ●
- failed previous fusion. .
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNH, MNI, NKB
Device Description
The Malibu Spinal System includes titanium alloy polyaxial reduction screws with a cobalt alloy component. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of a screw body and housing assembly. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will also include locking caps in two different sizes. These items are designed to be part of the stand alone Malibu Spinal System, but are compatible with and will work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will offer a wide variety of instruments that range from modular taps to angled in-situ benders. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, aluminum, and Radel. These items are supplied "NON-STERILE" and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, thoracic, lumbar, and sacral spine, L5-S1 vertebra, L3 to sacrum, T1-L5
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)
Mechanical Strength: "See test results"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K031175, K002607, K992168, K993503, K021623, K031381, K032739/S1, K043232
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KOS 1942
JUL 2 7 2005
CONFIDENTIAL
Malibu Spinal System
510(K) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.
| Submitter Information: | SeaSpine, Inc.
Contact: Diana Smith
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.
Contact: Diana Smith, Manager of
Regulatory Affairs and Quality Assurance
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
| Date Summary Prepared: | July 12, 2005 |
| Classification Name: | Pedicle Screw Spinal System
MNH (Class II) - 888.3070(b)(1)
MNI (Class II) - 888.3070(b)(1)
NKB (Class III) - 888.3070(b)(2)
Spinal Interlaminal Fixation Orthosis
KWP (Class II) - 888.3050 |
| Common/Usual Name: | Polyaxial Screws, Polyaxial Reduction
Screws, Locking Caps, Components, and
Instruments |
| Device Trade Name: | Malibu Spinal System |
The devices used for comparison in this summary are Synthes Spine Company's Synthes Click'X Monoaxial Screw System (K031175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168) and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/S1 and K043232).
- Intended Use: (The statements of intended use are identical.)
The intended use of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate devices. The intended use of the Malibu Spinal System is as a
19
1
Malibu Spinal System
temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:
- degencrative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis, .
- trauma (i.e., fracture or dislocation), .
- spinal stenosis. .
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- spinal tumor, .
- pseudoarthrosis, and/or ◆
- failed previous fusion. ●
The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to 71-L5 and are as follows:
- . degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- . spondylolisthesis
- trauma (i.e., fracture or dislocation), ●
- spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), .
- ◆ tumor,
- pseudarthosis, and/or ●
- failed previous fusion. .
2. Description:
The Malibu Spinal System includes titanium alloy polyaxial reduction screws with a cobalt alloy component. Both screw types will be offered in numerous diameters and lengths. The screw is comprised of a screw body and housing
20
2
CONFIDENTIAL
Malibu Spinal System
assembly. Both screws are designed to be part of the Malibu system, but are compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will also include locking caps in two different sizes. These items are designed to be part of the stand alone Malibu Spinal System, but are compatible with and will work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The Malibu Spinal System will offer a wide variety of instruments that range from modular taps to angled in-situ benders. These various instruments will be made primarily from various grades of stainless steel with a few components made from titanium alloy, aluminum, and Radel. These items are supplied "NON-STERILE" and must be sterilized prior to use.
3. Technological Characteristics:
The polyaxial screws, polyaxial reduction screws, locking caps, components, and instruments in this notification are components of a new stand alone system called Malibu Spinal System, but are designed to be compatible with and work in conjunction with the components in the current SeaSpine UCR Spinal System. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.
4. Comparison Analysis:
The overall designs of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the Malibu Spinal System polyaxial screws, polyaxial reduction screws, locking caps, and components to the predicate devices.
21 C
3
KOS નિનડ
CONFIDENTIAL
Malibu Spinal System
| Feature | Malibu Spinal System | Synthes
Click'X
Monoaxial
System | Moss Miami
Spinal System | SeaSpine UCR
Spinal System | Substantially
Equivalent |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------|-------------------------------|-----------------------------|
| Intended Use | The intended use of the
Malibu Spinal System is as
a temporary or permanent
posterior, non-cervical
implant to correct spinal
disorders and provide
stabilization of the spine to
permit the biological
process of spinal fusions to
occur. | Similar | Similar | Similar | Yes |
| Indications for
Use | Degenerative disc disease
(DDD) as defined by back
pain of discogenic origin
with degeneration of the
disc confirmed by patient
history and radiographic
studies.
spondylolisthesis,
trauma (i.e., fracture or
dislocation),
spinal stenosis,
deformities or curvatures
(i.e., scoliosis, kyphosis,
and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion. | Similar | Similar | Similar | Yes |
| Design | Iliac monoaxial screws,
monoaxial screws, locking
caps, rods, hooks, and
components | Similar | Similar | Similar | Yes |
| Iliac
Monoaxial
Screws | See prints | Similar | Similar | Similar | Yes |
| Monoaxial
Screws | See prints | Similar | Similar | Similar | Yes |
| Caps | See prints | Similar | Similar | Similar | Yes |
| Laminar
Hooks | See prints | Similar | Similar | Similar | Yes |
| Pedicle Hooks | See prints | Similar | Similar | Similar | Yes |
| Offset Hooks | See prints | Similar | Similar | Similar | Yes |
| Material | Titanium alloy | Similar | Similar | Similar | Yes |
| Sterile | Non-sterile | Similar | Similar | Similar | Yes |
| Method of
Sterilization | High-temperature steam | Similar | Similar | Similar | Yes |
| Mechanical
Strength | See test results | Similar | Similar | Similar | Yes |
Table 1: Summary of Design Comparison | ||||||
---|---|---|---|---|---|---|
-- | -- | --------------------------------------- | -- | -- | -- | -- |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 7 2005
Ms. Diana Smith Manager of Regulatory Affairs and Quality Assurance SeaSpine, Inc. 2302 La Miranda Drive Vista, California 92801
Re: K051942
Trade/Device Name: Malibu Spinal System Regulation Number: 21 CFR 888.3050, 21 CFR 888.3070 Regulation Name: Spinal interlaminal fixation orthosis, Pedicle screw spinal system Regulatory Class: III Product Code: KWP, MNH, MNI, NKB Dated: July 12, 2005 Received: July 18, 2005
Dear Ms. Smith:
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.
5
Page 2 - Ms. Diana Smith
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Stupt Curler
Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Malibu Spinal System
Indications for Use Statement
KOS 1442
510(k) Number (if known):
Device Name: Malibu Spinal System
Indications for Use:
The intended use of the Malibu Spinal System, polyaxial screws, polyaxial reduction screws, locking caps, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the Malibu Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the Malibu Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally . mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis. ●
- trauma (i.c., fracture or dislocation), ●
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- . spinal tumor,
- pscudoarthrosis, and/or .
- failed previous fusion.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X |
---|---|
------------------------------------------------- | --- |
AND/OR
| Over-The-Counter-Use
(21 CFR 807 Subpart C) | |
---|---|
------------------------------------------------ | -- |
(Division Sign-Off) DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).Division of General, Restoralities of CDRH, Office of Device Evaluation (ODE) and Neurological Devices
KOS1942 510(k) Number_
26
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7
Malibu Spinal System
Indications for Use Statement continued
The intended use and indications of the Malibu Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis .
- trauma (i.e., fracture or dislocation), .
- spinal stenosis, ◆
- . deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- . tumor,
- ◆ pseudarthosis, and/or
- failed previous fusion. .
Prescription Use | X |
---|---|
(Part 21 CFR 801 Subpart D) | |
AND/OR | |
Over-The-Counter-Use | |
(21 CFR 807 Subpart C) |
(Division Sign-Off)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).
Division of General, Restorative. Concurrence of CDRH, Office of Device Evaluation (ODE)
and Neurological Devices
510(k) Number K051942
27