(29 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, fasteners) for internal fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used for internal fixation of fractures, which is a therapeutic intervention aimed at restoring function and healing.
No
This device is described as an internal fixation system for fractures, not as a tool to diagnose or identify medical conditions. Its purpose is to treat, not to diagnose.
No
The device description explicitly states it consists of plates and screws made from stainless steel, which are physical hardware components.
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 device for the internal fixation of bone fractures in the proximal femur. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as plates and screws made of stainless steel, designed for implantation into the bone. This is consistent with a surgical implant, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The OsteoCentric Integrated Hip Fastener System is a surgical implant used to treat bone fractures.
N/A
Intended Use / Indications for Use
The OsteoCentric Integrated Hip Fastener System is indicated for stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.
The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including intracapsular, transcervical, and subcapital fractures.
Product codes (comma separated list FDA assigned to the subject device)
JDO, KTT
Device Description
The OsteoCentric Integrated Hip Fastener System is internal fixation of intertrochanteric and femoral neck fractures of the proximal femur. The OsteoCentric Integrated Hip Fastener System consists of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. Integrated Hip Fasteners which are lag screws implanted through the femoral neck and head are offered in Ø11, Ø13, & Ø15mm sizes with lengths ranging from 50 – 140mm in 5mm increments. Hip side plates are offered in 1-hole to 19-hole configurations (48 – 330mm length). 6.0mm support fasteners are offered in 55 – 125mm lengths. 5.2mm shaft fasteners are offered in 28 – 46mm locking fasteners for the trochanter plate are offered in 16 – 40mm lengths. Compression and attachment screws are also available. Devices are provided non-sterile. All implantable devices are manufactured from stainless steel per ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur (intertrochanteric and femoral neck fractures), femoral neck and head
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.
K210247, K182154, K062066, K953607
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 18, 2023
OsteoCentric Technologies Todd Evans Sr. Director of Quality & Regulatory Affairs 75 West 300 North Suite 150 Logan, Utah 84321
Re: K230764
Trade/Device Name: OsteoCentric Integrated Hip Fastener System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDO, KTT Dated: March 17, 2023 Received: March 20, 2023
Dear Todd Evans:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Limin S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
Submission Number (if known)
Device Name
OsteoCentric Integrated Hip Fastener System
Indications for Use (Describe)
The OsteoCentric Integrated Hip Fastener System is indicated for stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.
The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including intracapsular, transcervical, and subcapital fractures.
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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| K230764 Page 1 of 2 | |||
|---|---|---|---|
| 510(k) #: K230764 | 510(k) Summary | Prepared on: 2023-04-17 |
| Contact Details | 21 CFR 807.92(a)(1) | ||
|---|---|---|---|
| Applicant Name | OsteoCentric Technologies | ||
| Applicant Address | 75 West 300 North Suite 150 Logan UT 84321 United States | ||
| Applicant Contact Telephone | 1-800-969-0639 | ||
| Applicant Contact | Mr. Todd Evans | ||
| Applicant Contact Email | todd.evans@osteocentric.com |
| Device Name | 21 CFR 807.92(a)(2) | ||
|---|---|---|---|
| Device Trade Name | OsteoCentric Integrated Hip Fastener System | ||
| Common Name | Single/multiple component metallic bone fixation appliances and accessories | ||
| Classification Name | Device, Fixation, Proximal Femoral, Implant | ||
| Regulation Number | 888.3030 | ||
| Product Code | JDO,KTT |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
|---|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K210247 | OsteoCentric Integrated Hip Fastener System | JDO | |
| K182154 | Synthes Femoral Neck System (FNS) | KTT | |
| K062066 | Stryker Omega 3 | KTT | |
| K953607 | Synthes Dynamic Hip Screw (DHS) | JDO |
| Device Description Summary | 21 CFR 807.92(a)(4) | ||
|---|---|---|---|
| ---------------------------- | -- | -- | --------------------- |
The OsteoCentric Integrated Hip Fastener System is internal fixation of intertrochanteric and femoral neck fractures of the proximal femur. The OsteoCentric Integrated Hip Fastener System consists of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. Integrated Hip Fasteners which are lag screws implanted through the femoral neck and head are offered in Ø11, Ø13, & Ø15mm sizes with lengths ranging from 50 – 140mm in 5mm increments. Hip side plates are offered in 1-hole to 19-hole configurations (48 – 330mm length). 6.0mm support fasteners are offered in 55 – 125mm lengths. 5.2mm shaft fasteners are offered in 28 – 46mm locking fasteners for the trochanter plate are offered in 16 – 40mm lengths. Compression and attachment screws are also available. Devices are provided non-sterile. All implantable devices are manufactured from stainless steel per ASTM F138.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The OsteoCentric Integrated Hip Fastener System is indicated for stable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.
The OsteoCentric Integrated Hip Fastener System is indicated for femoral neck fractures including
4
intracapsular, transcervical, and subcapital fractures.
Indications for Use Comparison
The OsteoCentric Integrated Hip Fastener System has the same intended use and substantially similar indications for use as the previously cleared primary predicate device (K210247).
The OsteoCentric Integrated Hip Fastener System has the same intended use as and substantially similar indications for use as the secondary predicate devices (K182154, K062066, K953607).
The proposed indications for use statement does not alter the therapeutic effect or use of the implants. In conclusion, the OsteoCentric Integrated Hip Fastener with updated indications for use statement is substantially equivalent to the predicate devices.
Technological Comparison
21 CFR 807.92(a)(6)
Design changes to include an 11mm Integrated Hip Fastener and 1 & 2-hole versions (48 & 58mm) of the Side Plate do not introduce a new worst-case condition. The change to the Intended use of the intended use of the device and does not introduce new indications. The changes to design and indications for use does not change the therapeutic effect or use of the implants.
The OsteoCentric Integrated Hip Fastener System is identical to the primary predicate device with respect to sterilization, manufacturing methods, and material. Design changes include the addition of an 11mm Integrated Hip Fastener, the addition of a 1 & 2-hole versions of the Side Plate (48 & 58mm), and additional barrel angles of the Side Plate (130° - 150°). These design changes do not introduce a new worst-case mechanical condition.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
In conclusion, the OsteoCentric Integrated Hip Fastener with updated indications for use statement is substantially equivalent to the predicate devices.