(106 days)
No
The document describes a mechanical external fixation system and a material change for existing components. There is no mention of AI or ML.
Yes.
The device, an external fixation system for bone fracture fixation, osteotomy, arthrodesis, and correction of deformity, is used to treat or manage medical conditions, thereby qualifying as a therapeutic device.
No
The device is described as an external fixation system used for stabilizing fractures and correcting deformities. There is no mention of it being used to diagnose conditions or processes.
No
The device description explicitly states it includes physical components like clamps, couplings, and rods, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device's function as a mechanical system for stabilizing bone fractures, osteotomies, arthrodesis, and correcting deformities. This is a structural and mechanical function, not a diagnostic one performed on in vitro samples.
- Device Description: The description details the components (clamps, couplings, rods, pins) and their use in stabilizing bones. This aligns with a mechanical fixation device, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in these samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The Hoffmann II External Fixation System is a surgical device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
The Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
The indications for use of metallic external fixation devices include:
- Bone fracture fixation .
- Osteotomy .
- Arthrodcsis
- Correction of deformity .
- Revision procedures where other treatments or devices have been unsuccessful .
- Bone reconstruction procedures .
Product codes (comma separated list FDA assigned to the subject device)
87LXT, 87JEC
Device Description
The Hoffmann II External Fixation System originally cleared under K952730, K971755, K003211 and K031941 includes clamps, couplings and rods used in conjunction with half pins or transfixing pins of the Hoffmann External Fixation System cleared under K861766 and is intended to be used for the stabilization of fractures of the tibia, femur, liumerus, radius or pelvis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia, femur, liumerus, radius or pelvis
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)
Analysis and testing of the alternate material used on the Hoffmann II External Fixation demonstrated equivalent stability and performance compared to its predicate device. This was done by analyzing different contributions of the subject Hoffmann II.External Fixation components made of Custom 455 with components of Hoffmann II. MRI System made from the proposed Biodur material.
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.
K952730, K971755, K003211, K031941
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.
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
JAN 1 4 2011
510(k) Summary of Safety and Effectiveness: Hoffmann II, External, FixationLine Extension
| Proprietary Name: | Hoffmann II External Fixation System Line Extension |
|---|---|
| Common Name: | External Fixation System |
| Classification Name and Reference: | Single Multiple component metallic bone fixation appliance and |
| accessories, 21 CFR §888.3030 and | |
| Smooth or Threaded Metallic Fixation Fastener | |
| 21 CFR §888.3040 | |
| Regulatory Class: | Class II |
| Product Codes: | 87LXT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple |
| Components Metal Composite | |
| 87JEC: Component, Traction, Invasive | |
| For Information contact: | Zamir Bar-David |
| Regulatory Affairs consultant | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| (201) 831-6455 (Phone) | |
| (201) 831-3365 (Fax) | |
| zamir.bardavid@stryker.com | |
| 510(k) Alternate Contact Person: | Avital Merl-Margulies |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| (201) 831-6365 (Phone) | |
| (201) 831-3365(Fax) | |
| avital.merl.margulies@stryker.com (c-mail) | |
| Date Prepared: | September 29, 2010 |
2
1
Kl02885
Description:
The Hoffmann II External Fixation System originally cleared under K952730, K971755, K003211 and K031941 includes clamps, couplings and rods used in conjunction with half pins or transfixing pins of the Hoffmann External Fixation System cleared under K861766 and is intended to be used for the stabilization of fractures of the tibia, femur, liumerus, radius or pelvis.
Intended Use:
Hoffmann II External Fixation System consists of a system of clamps, couplings and used to provide stabilization of open and/or unstable fractures of the tibia, femur, humerus, radius or pelvis, and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation.
Indications:
The Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may proclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
The indications for use of metallic exteriial fixation devices include:
- Bone fracture fixation ●
- Osteotomy .
- Arthrodesis .
- Correction of deformity 0
- Revision procedures where other treatments or devices have been unsuccessful o
- Bone reconstruction procedures G
Proposed Modification:
This special 510(k) submission is intended to provide an alternate stainless steel material (Biodir 108) to manufacture Hoffinann II coupling components: Currently the subject Hoffmann II components are manufactured from stainless steel, Custom 455.
Summary of Data:
Analysis and testing of the alternate material used on the Hoffmann II External Fixation demonstrated equivalent stability and performance compared to its predicate device. This was done by analyzing different contributions of the subject Hoffmann II.External Fixation components made of Custom 455 with components of Hoffmann II. MRI System made from the proposed Biodur material.
ﻟﺴﺎ
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol resembling an abstract caduceus or a bird-like figure with three lines forming the body and a wavy line at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp % Mr. Zamir Bar-David 325 Corporate Drive Mahwah, New Jersey 07430
JAN 1 4 2011
Re: K102885
Trade/Device Name: Hoffmann II External Fixation System Line Extension Regulation Number: 21 CFR 888.3040 Regulation Name: Single multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: JEC, LXT Dated: December 20, 2010 Received: December 21, 2010
Dear Mr. Bar-David:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
. . . . . . . .
and the country of the count
3
Page 2 -Mr. Zamir Bar-David
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
-fy B. nh
Mark N. Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Hoffmann II External Fixation Line Extension
Special 510(k)
Indications for Use
510(k) Number (if known): K102885
Device Name: Hoffmann II External Fixation System Line Extension
Indications for Use:
The Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
The indications for use of metallic external fixation devices include:
- Bone fracture fixation .
- Osteotomy . �
- . Arthrodcsis
- Correction of deformity . �
- Revision procedures where other treatments or devices have been unsuccessful . O
- Bone reconstruction procedures .
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Page 1 of 1 | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| ------------- | -------------------------------------------------------- |
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510(k) Number | K102885 | 27 |
|---|---|---|
| --------------- | --------- | ---- |