(48 days)
Not Found
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a hip screw system used for fixation/stabilization of fractures, indicating its intended use to treat or manage a medical condition.
No
The device is a compression hip screw system used for fixation and stabilization of fractures, not for diagnosis.
No
The device description clearly details a physical implantable device made of stainless steel, including a lag screw, side plate, and compression screw, intended for surgical fixation of hip fractures. It does not describe any software component.
Based on the provided text, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the ODi Ultimate Compression Hip Screw is a surgical implant used to fix and stabilize bone fractures in the proximal femur. It is a mechanical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of testing bodily samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.
Product codes
HWC
Device Description
The Orthopedic Designs, Inc. Ultimate Compression Hip Screw is a cannulated lag screw to be used with a standard side plates for fracture fixation and stabilization of the proximal femur until bony union can occur.
ODi will manufacture the hip screw system from 316L and 22-13-5 stainless steel, which meet ASTM F138-92 and ASTM F1314-95 respectively. The 22-13-5 is used on the side plate and the lag screw tang where greater strength is desired. These materials are compatible and similar to those used in other marketed devices of similar design, dimension and configuration.
The distal end of the hip screw is keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the screw within the head of the femur. Several keyed sizes are available to be compatible with specific side plate systems of similar design. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the screw. A locking element is provided on the compression screw to prevent a common natural migration of the compression screw from the lag attachment
Additionally the hip screw has deployable tangs, comparable to several marketed anchor devices, that may be deployed if necessary to increase purchase of the lag screw. These anchors may also be retracted for removal of the lag screw if and when it is necessary.
The hip screw and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution.
A range of screw component sizes and lengths sizes will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
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)
No performance standards applicable to the fixation bone screw have been established by the FDA. However the 316-L and 22-13-5 stainless steel used to manufacture the ODi Ultimate Compression Hip Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F138-92 and ASTM F1314-95 respectively).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K781762, K823548, K900584, K850886, K872223, K955306, K922295, K791619, K861178, K946156
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 2 0 1999
K984331
Premarket Notification
510(k) Summary of Safety and Effectiveness Information
For Release Upon Request Only
November 28, 1998 Date of Preparation:
Regulatory Authority:
Safe Medical Devices Act of 1990, 21 CFR 807.92
Company Name / Contact:
| Company: | ODi (Orthopedic Designs, Inc.)
6971 1st Ave. North
St. Petersburg, FL 33710 |
| ---------- | ----------------------------------------------------------------------------------- |
|---|
Contact: Jeff Godsted (727) 343-0338
| Establishment Registration Number: | The registration number for
Orthopedic Designs, Inc. is
pending |
|------------------------------------|-----------------------------------------------------------------------|
| Classification Name: | Screw, Fixation, Bone |
| Classification Reference: | 21 CFR § 888.3040 |
|---|---|
| Common Used Name: | Orthopedic Compression Bone Screw |
| Device Product Code: | HWC |
| Classification Panel: | 888 - Orthopedic Devices |
| Trade Proprietary Name: | ODi Ultimate Compression Hip Screw |
Proposed Regulatory Class:
The FDA has classified similar products as a Class II device by the Orthopedic Device Section of the Surgical and Rehabilitation Devices Panel at Section 888-3040. The product code generally referred to is HWC (Product Code: HWC), and ODi submits this application under this designation.
1
Performance Standards:
No performance standards applicable to the fixation bone screw have been established by the FDA. However the 316-L and 22-13-5 stainless steel used to manufacture the ODi Ultimate Compression Hip Screw meets the chemical and mechanical requirements in voluntary standards established by the American Society for Testing and Materials (ASTM F138-92 and ASTM F1314-95 respectively).
Package and Labeling:
Package labeling has been developed to industry standards. Packaging is also standard commercially available type quality and is stored in a fashion which prevents damage to the container or package.
Device Description:
The Orthopedic Designs, Inc. Ultimate Compression Hip Screw is a cannulated lag screw to be used with a standard side plates for fracture fixation and stabilization of the proximal femur until bony union can occur.
ODi will manufacture the hip screw system from 316L and 22-13-5 stainless steel, which meet ASTM F138-92 and ASTM F1314-95 respectively. The 22-13-5 is used on the side plate and the lag screw tang where greater strength is desired. These materials are compatible and similar to those used in other marketed devices of similar design, dimension and configuration.
The distal end of the hip screw is keyed, but not threaded, thereby allowing the screw to slide within the barrel of the side plate while preventing rotation of the screw within the head of the femur. Several keyed sizes are available to be compatible with specific side plate systems of similar design. Immediate compression may be obtained with the use of a compression screw threaded into the inner canal of the screw. A locking element is provided on the compression screw to prevent a common natural migration of the compression screw from the lag attachment
Additionally the hip screw has deployable tangs, comparable to several marketed anchor devices, that may be deployed if necessary to increase purchase of the lag screw. These anchors may also be retracted for removal of the lag screw if and when it is necessary.
The hip screw and instruments are similar in design, materials and intended use to other 510(k) cleared devices/instruments which are in commercial distribution.
2
A range of screw component sizes and lengths sizes will be made available, offering a range of fracture compression. The components are designed to be manually or mechanically inserted using common (e.g. American Orthopedic) manual and power instrumentation.
Indications for Use:
The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures. intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.
Contra-indications for Use:
The ODi Ultimate Compression Hip Screw is not intended for use in patients with the following conditions:
-
- Active local Infection.
-
- Metal sensitivity or allergic reaction to foreign bodies.
-
- Other conditions that may place the patient at risk.
-
- When quality of bone stock prevents secure seating of the screws.
Substantial Equivalent Devices:
Orthopedic Designs, Inc. believes the ODi Ultimate Compression Hip Screw is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization. Within the proposed class, the following devices are used as predicate devices for comparison:
| Howmedica Compression Hip Screw System | (K781762) |
|---|---|
| Howmedica Compression Hip Screw Sideplate | (K823548) |
| Howmedica Alta Lag Screw & Compression Screw | (K900584) |
| Howmedica Omega Compression Screw System | (K850886) |
| (K872223) | |
| Howmedica Omega+ Compression Hip Screw System | (K955306) |
| Howmedica Omega Plus Compression Hip System | (K922295) |
| Synthes DHS Hip Screw | (K791619) |
3
Substantial Equivalent Devices continued:
Ace Cannulated Hip Screw and Captured Hip Screw System Richards KeyLock System Richards Kwik-Key Richards Ambi Compression Hip Screw Richards Classic Zimmer Compression Hip Screw with ECT Zimmer Free-Lock Zimmer Versa-Fx Orthopedic Equipment Company's (OECO.C.) Compression Hip Screw Plate Wright Hip Compression Screw/Plate Wright Concise Compression Hip Screw System Wright Cannulated Plus Screw System Depuy Combined NoLok /Keyed Compression Hip Screw System (K861178), (K946156)
Each of these products are commercially available and marketed Class II devices indicated for similar use.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1999
Mr. Jeff Godsted Vice President of Legal and Regulatory Affairs Orthopedic Designs, Inc. 6971 1st Avenue North 33710 St. Petersburg, Florida
Re: K984331 ODi Ultimate Compression Hip Screw Trade Name: Regulatory Class: II Product Code: HWC Dated: November 27, 1998 Received: December 3, 1998
Dear Mr. Godsted:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Mr. Jeff Godsted
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D.
a M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEVICE INDICATIONS FOR USE
Page 1 of 1
510(k) Number: 1984331
Device Name: ODi Ultimate Compression Hip Screw
Indications For Use:
The ODi Ultimate Compression Hip Screw will be used on indications that are common with presently marketed compression hip screw systems. The primary indications are for fixation/stabilization of intertrochanteric fractures, intracapsular fractures and some high subtrochanteric fractures. The device is intended to stabilize fragments of the fracture until bony union can occur. The installed device is not intended for weight bearing prior to the fracture showing evidence of union.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (per 21 CFR 801.109) OR
Over-The-Counter
(Optional Format 1-2-96)
signature
aral Restorative De 198433