(16 days)
Not Found
No
The provided text describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is a medical implant used to stabilize fractures, which helps in the healing process but does not directly "treat" a disease or condition in the same way a therapeutic device might through energy, substance, or non-invasive means. It provides mechanical support rather than active treatment.
No
The device is a system for internal fixation of femoral fractures, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly indicates a "Gliding Nail System," which is a physical implant used for internal fixation of bone fractures. This is a hardware device, not software.
Based on the provided information, the SLIM Gliding Nail System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a surgical implant for fixing bone fractures in the femur. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description reinforces that it's a system for internal fixation of bone fractures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
The SLIM Gliding Nail System is a medical device used for surgical treatment, not for diagnosis.
N/A
Intended Use / Indications for Use
The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:
- Pertrochanteric femoral fractures .
- Subtrochanteric femoral fractures and .
- Lateral femoral neck fractures .
Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
Product codes
KTT
Device Description
The SLIM Gliding Nail Systems designed for internal fixation in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. The system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral neck or trochanter region and femoral shaft fractures, proximal femur
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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K033763
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510 (k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
Prepared:
December 1, 2003
Applicant:
PI.US Orthopedics 6055 Lusk Boulevard San Diego, CA 92121-2700
| Telephone: | 888-741-7587 |
|---|---|
| Fax: | 888-741-4002 |
Device Name:
Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Original Predicate Device:
Registration Number: Owner Operator Number:
Appliance, Fixation. Nail/Blade/Plate Combination, Multiple Component SLIM Gliding Nail System Class II Orthopedic 21 CFR 888.3030 KTT SI.IM Gliding Nail System, K020240 The indications for use have not changed and are identical to the predicate device. 2086141 9034096
Device Description:
The SLIM Gliding Nail Systems designed for internal fixation in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. The system is also suitable for medial femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
Indications for Use:
The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:
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K033763
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- Pertrochanteric femoral fractures .
- Subtrochanteric femoral fractures and .
- Lateral femoral neck fractures .
Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
Comparison to the Original Predicate Device:
The legally marketed predicate device to which this device is substantially equivalent is the SI IM Gliding Nail System, K020240
II Regulatory Class: Product Code: K.I.I.
original PLUS Orthopedics SLIM Gliding Nail System to the new Comparison of configuration.
| Item | Original PLUS Product | Proposed modified product |
|---|---|---|
| Product Name | SLIM Gliding Nail System | SLIM Gliding Nail System |
| Use | Single use | Single use |
| Fixation | Compression Hip Nail | Compression Hip Nail |
| Constraint | Constrained | Constrained |
| Material | Stainless Steel | Stainless Steel |
| Sizes | The blade comes in 11 sizes | The blade comes in 11 sizes |
| Indications for use | The SLIM Gliding Nail System is an all- | |
| purpose locking nail system for ensuring | ||
| primary load stability in: | The SLIM Gliding Nail System is an all- | |
| purpose locking nail system for ensuring | ||
| primary load stability in: | ||
| Pertrochanteric femoral fractures | Pertrochanteric femoral fractures | |
| Subtrochanteric femoral fractures | Subtrochanteric femoral-fractures | |
| and | and | |
| Lateral femoral neck fractures | Lateral femoral neck fractures | |
| Internal fixation with the SLIM Gliding | ||
| Nail System is indicated in all | ||
| combination injuries involving the lateral | ||
| femoral neck or trochanter region and | Internal fixation with the SLIM Gliding | |
| Nail System is indicated in all | ||
| combination injuries involving the | ||
| lateral femoral neck or trochanter region |
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femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
The only design modification to the SLIM Gliding Nail System is the removal of the collar from the gliding blade.
Summary:
The device and the predicate device have similar design characteristics and intended use. The modified device is substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of three curved lines, resembling a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2003
Mr. Neil Delaney Plus Orthopedics, Inc. 6055 Lusk Boulevard San Diego, California 92121-2700
Re: K033763
Trade/Device Name: SLIM Gliding Nail System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Codes: KTT Dated: December 1, 2003 Received: December 2, 2003
Dear: Mr. Delaney:
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); labcling (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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Neil Delaney
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 vours.
Sincerely yours,
Mark N. Millam
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
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Page _ of _
510 (k) Number (If Known): Ko 33263
Device Name: SLIM Gliding Nail System
Indications for Use:
The SLIM Gliding Nail System is an all-purpose locking nail system for ensuring primary load stability in:
- Pertrochanteric femoral fractures .
- . Subtrochanteric femoral fractures and
- . Lateral femoral neck fractures
Internal fixation with the SLIM Gliding Nail System is indicated in all combination injuries involving the lateral femoral neck or trochanter region and femoral shaft fractures. Thanks to its biomechanical characteristics, the SLIM Gliding Nail System is also suitable for medical femoral neck fractures with retention of the head and simple femoral shaft fractures down to the distal metaphysis. Gliding nail fixation can also be used to secure pathological fractures or to provide weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
or Over the counter use
for Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Number K033763