(136 days)
Not Found
No
The device description and intended use focus on the material and physical properties of biodegradable pins for fracture fixation. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device, ReFIX Biodegradable Pins, is intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies, and arthrodeses, which are medical treatments to restore function or correct deformities, thus qualifying it as a therapeutic device.
No
The device is described as "Biodegradable Pins" intended for "fixation and/or alignment of fragments" in bones, osteotomies, and arthrodeses. This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states that the device is comprised of physical pins manufactured from PLLA and PLGA, available in various diameters and lengths. This indicates a physical hardware component, not a software-only device.
Based on the provided information, the ReFIX Biodegradable Pins are not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended use and device description of the ReFIX pins clearly state they are used for the fixation and/or alignment of bone fragments within the body.
- The device is an implantable medical device used in surgical procedures. This falls under the category of medical devices used for treatment or structural support, not for in vitro diagnostic testing.
The information provided describes a surgical implant used for orthopedic procedures, which is distinct from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
For example, ReFIX pins are intended for use in the following procedures:
- fixation of phalangeal fusion and fracture .
- repair of metacarpal fusion and fracture
- fixation of hand and wrist fractures .
- fixation of metatarsal osteotomies .
- correction of hallux valgus .
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
Internal Fracture Fixation Devices based upon ReFIX™ Pins are comprised of themal Package Pakken Divers are widely used in the orthopaedic specialty. The ReFTX Pins are manufactured from PLLA and PLGA. The pins are available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, each supplied in a length of 70mm. The pins are sized and trimmed intraction and materials are designed to address the indications cited.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-load bearing bones (phalangeal, metacarpal, hand, wrist, metatarsal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopaedic specialty
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)
Not Found
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.
K010983, K003659, K925098, K031712, K040500, K011522, K990291, K953194, K890902, K901456, K864912
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
APR 1 8 2005
510(K) SUMMARY
page 1 of 2
Subject 510(k) Number - K0433339
Sponsor
Xtremi-T, LLC
3131 Princeton Pike Bldg 5, Suite 200 Lawrenceville, New Jersey 08648
FDA Establishment Registration Number
3004613836
Official Contact
Shawn T. Huxel, President Xtremi-T, LLC 3131 Princeton Pike; Bldg 5, Suite 200 Lawrenceville, New Jersey 08648 Phone - (609) 896-0008 Fax - (908) 842-0310 Mobile - (908) 896-5893
Proprietary Name
ReFIX™ Internal Fixation Pins
Common Name
Biodegradable Internal Fixation Device
Classification Name and Reference
888.3040 -- Smooth or Threaded Bone Fixation Fastener
Regulatory Class Class II
Device Product Code (Panel 87) HTY
Date Prepared 14 March, 2005
Xtremi-T, LLC
Confidential
Pg 14 of 112
1
K043339
Page 2 of 2
Brief Description of Device
Brief Desoription of Internal Fracture Fixation Devices based upon ReFIX":" Pins are comprised of themal Package Pakken Divers are widely used in the orthopaedic specialty. The ReFTX Pins are manufactured from PLLA and PLGA. The
orthopaedic specialty. The ReFTX Pins are manufactured from exch supplied i orthopaedic specialty. The ReFTX Phis are niamatacanon and 4.5mm, each supplied in a
pins are available in diameters of 2.0mm, 2.7mm, 3.5mm, and 4.5mm, the ReFIX pins are available in diameters of 2.0mm, 2.7mm, Stance, atively using the ReFIX
length of 70mm. The pins are sized and trimmed intraction and materials are de length of 70mm. The pins are sized and unimited misues and materials are designed to address the indications cited.
Indications for Use
midications for USC ReFIX Biodegradable Pins are intended to use in and arthrodeses; and fixation
fragments of fractured non-load bearing bones, osted broads and fixation fragments of fractured non-load ocaring bones, osteochondral fragments and cancellous/non-load bearing fragments.
For example, ReFIX pins are intended for use in the following procedures:
- fixation of phalangeal fusion and fracture .
- repair of metacarpal fusion and fracture t
- fixation of hand and wrist fractures .
- fixation of metatarsal osteotomies .
- correction of hallux valgus ●
Basis for Substantial Equivalence
Dasis for Oubstantial equivalence of the ReFIX Pins is based on the equivalence in intended I no substantial verational principals, and indications to:
| DEVICE | Manufacturer | Trade Name |
|---|---|---|
| K010983 | Bionx | PLLA Pin |
| K003659 | Bionx | PLGA Pin |
| K925098 | Bionx | Biofix Pin |
| K031712 | Inion | OTPS Pin |
| K040500 | Biomet | Lactonail |
| K011522 | Biomet | Resorbable Bone Pins |
| K990291 | Biomet | Lactosorb Bone Pin |
| K953194 | Biomet | Lactosorb Bone Pin |
| K890902 | D&G | Biofix Pin |
| K901456 | J&J | Orthosorb |
| K864912 | J&J | PDS Pin |
END OF 510(K) SUMMARY
Xtremi-T, LLC
Pg 15 of 112
Confidential
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of an eagle.
APR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Shawn T. Huxel President, GM Xtremi-T, LLC 3131 Princeton Pike Building 5, Suite 200 Lawrenceville, New Jersey 08648
Re: K043339
K043339
Trade/Device Name: ReFix Internal Fracture Fixation Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: March 14, 2005 Received: March 15, 2005
Dear Mr. Huxel:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(t) premainted instally equivalent (for the indications
referenced above and have determined the device is substantial in interests a for use stated in the enclosure) the art acted predicate devices marketed in interstate for use stated in the enclosure) to regally mancetod proce Amendments, or to commerce prior to May 28, 1970, the chacanene with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance what approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosment Act (Act) that do not require to the general controls provisions of the Act. The Act. The Act. The You may, merelote, market the device, saloject or use ments for annual registration, listing of
general controls provisions of the Act include requirements michaeading and general controls provisions of the received required in the bronibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into or regulations affecting your device
it may be subject to such additional controls. Existing major regulation FDA it may be subject to such additional controls: "Intering and to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to Analysis can be lound in the Code of I edela. Regulation in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a subscribed with other requirements of the Act
that FDA has made a determination that your device complies with other requirements that FDA has made a decemmanon that your acered by other Federal agencies. You must or any Federal statules and regulations administered of the registration and listing (21).
comply with all the Act's requirements, including, but not limited to set comply with all the Act S requirements, mendants, wartice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Fart on ); good manafanting production in electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the el forth in the quality systems (QB) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
3
Page 2- Mr. Shawn T. Huxel
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin makemig your article walness of your device to a legally
premarket notification. The FDA finding of substantial end the permits vour premarket notification. The I DA Inding of oublication 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
s and the may of the may on 1100 m Marceless and the regulation entitled If you desire specific advice for your de vice on our ac access note the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . Also, please note the now o contact the Office of Comphalled at (240) 276 - 8 - 4 - 4 - 7 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 4 first from the Di "Misbranding by reference to premarket nonlication (1) of Act from the Division of Small .
other general information on your responsibilities under (800) 638-204) other general information on your responsion.comer Assistance at its toll-fire number (800) 638-2041 or Manufacturers, International and Consumer Assistantes artis courted to the result of the support/index.html.
Sincerely yours,
Stupt durelu
4 Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510 (K) NUMBER IF KNOWN: K043339
MANUFACTURER: Xtremi-T, LLC
DEVICE NAME: ReFIX Internal Fracture Fixation Pins
Indications:
ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of
ten the first and the collection beauts and arthrodeses; and ReFTX Biodegradable Plils are intention for assestomies and arthrodoses; and fragments of fractured mou-foad ocuring ochos, est. Secochondral fragments and
fixation and/or alignment of apical fragments, osteochondral fragments and
fixation and/or alig cancellous/non-load bearing fragments.
earses and
- fixation of phalangeal fusion and fracture .
- repair of metacarpal fusion and fracture �
- fixation of hand and wrist fractures .
- fixation of metatarsal osteotomies .
- correction of hallux valgus .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use yes or Over-the-Counter Use No
(Per 21 CFR 801.109) (Optional Format 1-2-1996)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K043339
Xtremi-T, LLC
Page 13 of 112
Confidential