(51 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant, with no mention of AI or ML.
Yes
The device is described as "Rush Medullary Pins" indicated for "fixation of bone fractures, for bone reconstruction, and for skeletal traction in alignment of long bone fracture segments," which are all therapeutic interventions.
No
The device is described as an implant used for internal fixation of bone fractures and reconstruction, not for diagnosis. Its function is to stabilize bone segments, not to identify or characterize medical conditions.
No
The device description clearly states it is a physical implant made of stainless steel, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Rush Medullary Pin is "inserted into the medullary canal of long bones to provide internal shaft fracture fixation." This is a surgical implant used within the body for mechanical support.
- Intended Use: The intended use is for "fixation of bone fractures, for bone reconstruction, and for skeletal traction." These are all mechanical and structural functions performed directly on the patient's body.
The device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
Rush Medullary Pins are indicated for use in fixation of bone reconstruction, and for skeletal traction in alignment of long bone fracture segments.
Rush Medullary Pins are indicated for use in fixation of bone fractures, for bone reconstruction, and for skeletal traction in alignment of long bone fracture segments.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The Rush Medullary Pin is inserted into the medullary canal of long bones to provide internal shaft fracture fixation. It achieves stabilization through the opposition of dynamic forces. The beveled point enables the surgeon to insert from the side of the bone with little chance of driving the pin through the opposing cortex. These devices are made from stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Performance and Conclusions:
- · Biocompatibility Biocompatibility testing on the Rush Pin material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
- · Performance Evaluation The subject devices were considered for conformance to material mechanical property standard ISO 5838-1, and were found to be in conformance with the standard. The engineering analysis shows the subject and predicate devices have identical material and cross-sectional geometrical properties, their bending strengths are substantially equivalent.
Conclusions: The data presented in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
- · Clinical data and conclusions were not needed for this submission.
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
§ 888.3040 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager P.O. Box 708 Warsaw, Indiana 46581
Re: K150626
Trade/Device Name: Rush Medullary Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 10, 2015 Received: March 11, 2015
Dear Mr. McKelvey:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
May 1, 2015
1
Page 2 - Mr. Stephen H. McKelvey
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Rush Medullary Pins
Indications for Use (Describe)
Rush Medullary Pins are indicated for use in fixation of bone reconstruction, and for skeletal traction in alignment of long bone fracture segments.
Type of Use (Select one or both, as applicable)
- ×
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
ng Services (301) 443-6740 EF 9
3
Image /page/3/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in lowercase blue letters. The font used for "zimmer" is sans-serif and appears to be a custom design.
| 510(k) Summary | |
|---|---|
| Sponsor: | Zimmer, Inc. |
| P.O. Box 708 | |
| Warsaw, IN 46581-0708 | |
| Contact Person: | Stephen H. McKelvey |
| Senior Project Manager, Trauma Regulatory Affairs | |
| Telephone: (574) 372-4944 | |
| Fax: (574) 371-8760 | |
| Date: | March 10, 2015 |
| Trade Name: | Rush Medullary Pins |
| Common Name: | Rush Pins |
| Classification Names | |
| and References: | Pin, Fixation, Smooth (HTY) |
| 21 § CFR 888.3040, Smooth or threaded metallic bone | |
| fixation fastener | |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Ortho Solutions Limited Trauma Implants for |
| Osteosynthesis (including Rush Medullary Pins) | |
| K110895 - cleared 12/19/2011 | |
| Purpose and Device Description: | The Rush Medullary Pin is inserted into the medullary |
| canal of long bones to provide internal shaft fracture | |
| fixation. It achieves stabilization through the opposition | |
| of dynamic forces. The beveled point enables the surgeon | |
| to insert from the side of the bone with little chance of | |
| driving the pin through the opposing cortex. These | |
| devices are made from stainless steel. | |
| Intended Use: | Rush Medullary Pins are indicated for use in fixation of |
| bone fractures, for bone reconstruction, and for skeletal | |
| traction in alignment of long bone fracture segments. |
4
| Comparison to Predicate Device: | The subject Rush Medullary Pins are identical in shape,
materials, and performance characteristics to the predicate
devices. Only the lengths of the subject and predicate
devices differ. The subject Rush Medullary Pins with
diameters equivalent to the predicate devices but with
different lengths were shown to be substantially equivalent
to the predicate devices. The indications for use for the
subject and predicate devices were shown to be
substantially equivalent. The subject device is provided
non-sterile as is the predicate device. |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions: |
- · Biocompatibility Biocompatibility testing on the Rush Pin material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
- · Performance Evaluation The subject devices were considered for conformance to material mechanical property standard ISO 5838-1, and were found to be in conformance with the standard. The engineering analysis shows the subject and predicate devices have identical material and cross-sectional geometrical properties, their bending strengths are substantially equivalent.
Conclusions: The data presented in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.
Clinical Performance and Conclusions:
- · Clinical data and conclusions were not needed for this submission.