(204 days)
Not Found
No
The summary describes a physical orthopedic screw made of biodegradable polymers and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used for fixation and alignment of fractured bones, osteotomies, and arthrodeses, which are supportive functions for healing rather than active therapeutic treatment.
No
Explanation: The device, ReFIX Screws, is intended for the fixation and alignment of fractured bones, osteotomies, and arthrodeses, acting as an internal fracture fixation device. It is a treatment device, not one that identifies or diagnoses a condition.
No
The device description clearly states that the device is comprised of physical screws made from biodegradable polymers, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ReFIX Screws Function: The description clearly states that ReFIX Screws are "Internal Fracture Fixation Devices." They are implanted inside the body to fix and align fractured bones.
- Intended Use: The intended use is for surgical procedures to stabilize bone fragments and fusions. This is a therapeutic intervention, not a diagnostic test.
The information provided describes a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but specifically not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing bone fragments.
For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.
Product codes
HWC
Device Description
ReFIX™ Screws are comprised of Internal Fracture Fixation Devices based upon biodegradable polymer fixation systems. Biodegradable polymers are widely used in the orthopaedic specialty. The ReFIX Screws are manufactured from PLLA and PLGA. The Screws are available in diameters ranging from 2.7mm to 6.0mm. ReFIX Screws are available in lengths ranging from 30mm to 60mm. The Screws are sized and trimmed intraoperatively using the ReFIX instrumentation according to the surgical technique. The sizes 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; ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; metacarpals, metatarsals and phalanges
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)
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.
K041189, K992301, K964970, K042295, K032447, K023022, K012001, K003077, K992947, K974876, K030900, K023887
Reference Device(s):
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
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SEP - 7 2005
510(K) SUMMARY
Subject 510(k) Number K050388
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 Screws
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) HWC
Date Prepared 25 April, 2005
Xtremi-T, LLC
1
page 2 of 2
Brief Description of Device
ReFIX™ Screws are comprised of Internal Fracture Fixation Devices based upon biodegradable polymer fixation systems. Biodegradable polymers are widely used in the orthopaedic specialty. The ReFIX Screws are manufactured from PLLA and PLGA. The Screws are available in diameters ranging from 2.7mm to 6.0mm. ReFIX Screws are available in lengths ranging from 30mm to 60mm. The Screws are sized and trimmed intraoperatively using the ReFIX instrumentation according to the surgical technique. The sizes and materials are designed to address the indications cited.
Indications for Use
ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments cancellous/non-load bearing bone fragments.
For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.
Basis for Substantial Equivalence
The substantial equivalence of the ReFIX Screws is based on the equivalence in intended use, materials, operational principals, and indications to:
| DEVICE | Manufacturer | Trade Name |
|---|---|---|
| K041189 | Arthrex | TRIMIT |
| K992301 | Biomet | Reunite Screw |
| K964970 | Biomet | Bonescrew |
| K042295 | Bionx | Smartscrew |
| K032447 | Bionx | Nugen FX |
| K023022 | Bionx | Nugen FX |
| K012001 | Bionx | Smartscrew |
| K003077 | Bionx | Smartscrew |
| K992947 | Bionx | Smartscrew |
| K974876 | Bionx | Distal Radius Screw |
| K030900 | Inion | OTPS System |
| K023887 | Inion | OTPS System |
END OF 510(K) SUMMARY
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 7 2005
Mr. Shawn T. Huxel President Xtremi-T, LLC 3131 Princeton Pike Building 5, Suite 200 Lawrenceville, New Jersey 08648
Re: K050388
Trade/Device Name: ReFIX™ Internal Fracture Fixation Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 18, 2005 Received: July 19, 2005
Dear Mr. Huxel:
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
3
Page 2-Mr. Shawn T. Huxel
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins lotter will and in your to FDA finding of substantial equivalence of your device to a legally premaired 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 in you attire 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 other generals, 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,
Signature
Mark N. Melkerson 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: K050388 MANUFACTURER: Xtremi-T, LLC DEVICE NAME: ReFIX Internal Fracture Fixation Screws
Indications:
ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing bone fragments.
For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and 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)
or
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off) Division of General, Restoral and Neurological Devices
510(k) Number C050388
Xtremi-T, LLC
Over-the-Counter Use
(Optional Format 1, 2, 100C)
(Optional Format 1-2-1996)
Confidential