(30 days)
Not Found
No
The summary describes a mechanical implant system (gliding nails and blades) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies mentioned are biomechanical fatigue tests, not studies related to algorithmic performance.
Yes
The device is an implantable medical device used for internal fixation of femoral fractures to ensure primary load stability. This directly contributes to the treatment and healing of injuries, classifying it as a therapeutic device.
No
The device is described as an "all-purpose locking nail system" for internal fixation of femoral fractures, which indicates it is a surgical implant used for treatment, not diagnosis. The "Intended Use" section outlines its application in stabilizing fractures, not in identifying them.
No
The device description explicitly details physical components (nails and blades) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fixing bone fractures in the femur. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as a "locking nail system" and "femoral neck blade," which are physical implants.
- 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 compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is a surgical implant used inside the body to stabilize fractures.
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 internal fixation with the Same of trochanter region and femoral shaft fractures. if worling the lateral londral rearacteristics, the SLIM Gliding Nail System is also r hanks to to blomoonamed. Shartures with retention of the head and simple femoral sunable for modial formeral host mastaphysis. Gliding nail fixation can also be used to shart fractures down to the distal model weight-bearing stability after varus and valgus revision osteotomies of the proximal femur.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
We added the following smaller nails to our predicate device (FRIEDL Gliding Nail System, K974409): - # 132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø - # 132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø - # 132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø, These 3 nails are narrower than the conventional nails, which 19 mm diameter proximally and 12 mm distally. - # 132140 Femoral Neck Blade, 75 mm length In addition, this 75 mm long femoral neck blade has been added to the existing range from 80 mm to 125 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical fatigue tests have been performed on the worst-case model. The test results of the smaller components were equal or better to the predicate and other commercially available devices, and they are sufficient for in vivo loading.
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.
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
§ 888.3030 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.
0
| SPECIAL 510(K) DEVICE MODIFICATION
SLIM Gliding Nail System
| January 22, 2002 | FEB 22 2002 | K020240 | page 1 of 2 | ||
|---|---|---|---|---|---|
| 510(k) Summary of Safety and Effectiveness | |||||
| 510(k) Summary of Safety and Effectiveness | |||||
| [in accordance with SMDA of 1990, 21 CFR 807.92(c)] | |||||
| Contact: | PLUS ORTHOPEDICS | ||||
| 6055 Lusk Blvd. | |||||
| San Diego, CA 92121 | |||||
| Tel: 858-550-3800 x 2506 | |||||
| Attn: Mr. Hartmut Loch, RAC | |||||
| Director, Regulatory Affairs | |||||
| Trade name: | SLIM Gliding Nail System | ||||
| Common name: | Compression Hip Nail | ||||
| Classification name: | Appliance, Fixation, Nail/Bl;ade/Plate Combination, Multiple Component | ||||
| § 888.3030, Class II, Product Code: KTT, 87 Orthopedic Device Panel | |||||
| Predicate Device: | FRIEDL Gliding Nail System, K974409 – S/E 2/19/1998 | ||||
| Device | |||||
| Modification | |||||
| Description: | We added the following smaller nails to our predicate device (FRIEDL | ||||
| Gliding Nail System, K974409): |
-
132071 Slim Gliding Nail, 125°, 220 mm, 17 mm / 11 mm Ø
-
132072 Slim Gliding Nail, 135°, 220 mm, 17 mm / 11 mm Ø
-
132073 Slim Gliding Nail, 125°, 180 mm, 17 mm / 11 mm Ø,
These 3 nails are narrower than the conventional nails, which 19 mm
diameter proximally and 12 mm distally.
-
132140 Femoral Neck Blade, 75 mm length
In addition, this 75 mm long femoral neck blade has been added to the
existing range from 80 mm to 125 mm. | | | | |
| Indications: | 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 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 | | | | |
1
SPECIAL 510(K) DEVICE MODIFICATION SLIM Gliding Nail System January 22, 2002
KAoyo
page 2 of 2
Contraindications include acute or chronic infections (local or systemic), Contraindications: serious lesions of muscles, nerves or blood vessels, which put the affected limb at risk, bony defects or poor bone quality, which might endanger the stability of the prosthesis, and any concurrent disease, which might interfere with the function of the implant.
Biomechanical fatigue tests have been performed on the worst-case Performance model. The test results of the smaller components were equal or better data: to the predicate and other commercially available devices, and they are sufficient for in vivo loading.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem resembling an abstract bird or stylized human figures, composed of three curved lines that suggest movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Mr. Hartmut Loch, RAC Director, Regulatory Affairs PLUS Orthopedics 6055 Lusk Boulevard San Diego, California 92121-2700
Re: K020240 Trade/Device Name: SLIM Gliding Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulatory Class: II Product Code: KTT Dated: January 22, 2002 Received: January 23, 2002
Dear Mr. Loch:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to tegans coment date of the Medical Device American processor of to Conninerce prior to May 20, 1978, are exactions of the Federal Food, Drug, de necs mat have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercere, market of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 to such additional controls. Existing major regulations affecting your device can may or subject to sach as a same as a legulations, 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 lease be devilode that I Dr. mination that your device complies with other requirements of the Act that I Dr Has Internand regulations administered by other Federal agencies. You must or any I edetar statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fart 877, accimig (21 CFR Part 820); and if applicable, the electronic form in the quinty by systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Hartmut Loch, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ought mains of substantial equivalence of your device to a legally premarket notification: "The PDF mailing sification 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 and 11 you desire specific act1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CHC Far 007.10 Idditionally, for questions on the promotion and advertising of Compliance at (301) 591-1097 Technological (301) 594-4639. Also, please note the your dones, pread "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation citined, "Trisotanaing of responsibilities under the Act may be obtained 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 yours,
A. Mch. N. Mullin.
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
4
Page 1 of
SPECIAL 510(K) DEVICE MODIFICATION SLIM Gliding Nail System January 22, 2002
510(k) Number: K020240
SLIM Gliding Nail System Device Name(s):
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 internal fixation with the Same of trochanter region and femoral shaft fractures. if worling the lateral londral rearacteristics, the SLIM Gliding Nail System is also r hanks to to blomoonamed. Shartures with retention of the head and simple femoral sunable for modial formeral host mastaphysis. Gliding nail fixation can also be used to shart fractures down to the distal model 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 NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K020240
Prescription Use X OR Over-The-Counter-Use __
(Per 21 CFR 801.109) (Optional format 1-2-96)