(23 days)
Not Found
No
The summary describes a mechanical implant (nail system) for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being used for the "alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthrodesis." These are all therapeutic actions.
No
The device is a medical implant (Compression Nail System) used for the alignment, stabilization, and fixation of bone fractures and deformities. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components (nails, screws, wires) that are inserted into the body, indicating it is a hardware medical device, not software-only.
Based on the provided information, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "Compression Nail System" inserted into the "medullary canal of long bones" for "alignment, stabilization and fixation of fractures," "correction of deformity," and "arthrodesis." This is a surgical implant used directly within the body for structural support and repair.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
Therefore, the IP-XS Compression Nail System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.
Product codes
HSB
Device Description
The IP-XS Compression Nail system is for bones with small comes in diameters of 3.5mm and 4.5mm. They have a circular cross section with multiple transverse holes for interlocking components. The two proximal transverse holes are elongated to allow the interlocking component to move axially and apply compression to the bone fragments. The proximal end has an internal axial threaded hole to receive a compression screw. Threaded Kirschner wires 02.0mm and 01.6mm are used as the interlocking components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medullary canal of long bones
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)
Cantilever testing, simulating loading that might be seen when this device is used for ankle fractures, was performed as well as validated FEA analysis. This testing indicates that the IP-XS Compression Nail will support the in-vivo loads expected to be seen for this application.
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
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Date August 14, 2003
Submitter
PLUS Orthopedics 6055 Lusk Blvd San Diego, CA 92121
Contact person
J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199
Common name Intramedullary nail
Classification name
Rod, Fixation, Intramedullary and Accessories per 21 CFR section 888.3020.
Equivalent Device
The IP-XS Compression Nail is similar in materials, design and indications as the Small Bone Nail (Accumed K031438) and SST Small Bone Locking Nail (Biomet).
Device Description
The IP-XS Compression Nail system is for bones with small comes in diameters of 3.5mm and 4.5mm. They have a circular cross section with multiple transverse holes for interlocking components. The two proximal transverse holes are elongated to allow the interlocking component to move axially and apply compression to the bone fragments. The proximal end has an internal axial threaded hole to receive a compression screw. Threaded Kirschner wires 02.0mm and 01.6mm are used as the interlocking components.
Intended Use
The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.
Summary Nonclinical Tests
Cantilever testing, simulating loading that might be seen when this device is used for ankle fractures, was performed as well as validated FEA analysis. This testing indicates that the IP-XS Compression Nail will support the in-vivo loads expected to be seen for this application.
SEP 1 0 2003
K032548
page 1 of 1
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2003
Mr. J.D. Webb PLUS Orthopedics 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K032548
Trade/Device Name: IP-XS Compression Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: August 14, 2003 Received: August 18, 2003
Dear Mr. Webb:
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.
2
Page 2 - Mr. J.D. Webb
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 yours,
Miriam C. Provost
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
3
510(k) number (if known): K0 305 4 8
Device Name:
Indications for Use:
IP-XS Compression Nail System Indications for Use
The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of deformity; and for arthordesis.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General, Neurological and Restorative Devices
510(k) Number
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional format 1-2-96)
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number_KO32548