ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)

K091619 · Anglefix · KTT · Sep 8, 2009 · Orthopedic

Device Facts

• Record ID: K091619
• Device Name: ANGLEFIX T LOCKING PLATE, MODELS AF-001 (PLATE), ST-1 (LOCKING SCREW)
• Applicant: Anglefix
• Product Code: KTT · Orthopedic
• Decision Date: Sep 8, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including: - Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones - Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures - Diaphyseal fractures . - Ankle fractures . - Simple, comminuted and depression fractures ● - Non-unions and malunions . - Osteotomies and bone reconstruction t - Fractures in normal or osteoporotic bone 9

Device Story

AngleFix T Locking Plate is a metallic bone fixation device designed for temporary stabilization of long bone fractures. The device consists of plates featuring threaded holes and 'finger holes' to accommodate screws and match patient anatomy. It is intended for use by orthopedic surgeons in clinical settings to stabilize fractures, including those in osteoporotic bone, non-unions, and following osteotomies. The device provides mechanical support to facilitate bone healing. It is a passive implantable device; no software or electronic components are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation plate with threaded holes and finger holes for screw fixation. Designed for temporary stabilization of long bones. Class II device under 21 CFR 888.3030.

Indications for Use

Indicated for temporary stabilization of long bone fractures in patients with normal or osteoporotic bone, including proximal/distal, metaphyseal, supracondylar, peri-articular, intra-articular, condylar, and diaphyseal fractures, as well as ankle fractures, non-unions, malunions, osteotomies, and bone reconstruction.

Regulatory Classification

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.

Predicate Devices

• Howmedica VariAx Locking plate System (K060613)
• Synthes AxSOS Plus Locking Plate System (K061012)
• Synthes 3.5mm LCP Distal Humerus System (K033995)

Submission Summary (Full Text)

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SEP 0 8 2009

K0916619

# 4. 510(k) Summary according to 807.92(c)

| Contact: | Mike Sinsheimer<br>AngleFix Tech, LLC.<br>1723 Beverly Drive<br>Charlotte, NC 28207<br>704-363-7532 |
|-----------------|-----------------------------------------------------------------------------------------------------|
| Trade Name: | AngleFix T Locking Plate |
| Product Class: | Class II |
| Classification: | 21 CFR §888.3030<br>Single/multiple component metallic bone fixation<br>appliances and accessories |
| Product Codes: | KTT |
| Panel Code: | 87 |

Indications for Use: The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:

- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
- Diaphyseal fractures .
- Ankle fractures .
- Simple, comminuted and depression fractures ●
- Non-unions and malunions .
- Osteotomies and bone reconstruction t
- Fractures in normal or osteoporotic bone 9

The AngleFix T Locking Plate consists of plates to accommodate the patients' anatomy. Each plate has threaded holes and "finger holes" for the corresponding screws.

Predicate Device(s):

Device Description:

and the Synthes AxSOS Plus Locking Plate System (K061012).

Performance Testing:

The pre-clinical testing performed indicated that the AngleFix T Locking Plate is substantially equivalent to the predicate devices and is adequate for the intended use.

Howmedica VariAx Locking plate System (K060613), the

Synthes 3.5mm LCP Distal Humerus System (K033995)

e i of

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's emblem in the center. The emblem features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design incorporated into it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

SEP 0 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 . Silver Spring, MD 20993-0002

AngleFix Tech, LLC % Silver Pine Consulting Mr. Richard Jansen, Pharm D. 135 Guild Avenue Apple Valley, Minnesota 55124

Re: K091619

Trade/Device Name: AngleFix T Locking Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: KTT Dated: May 31, 2009 Received: June 10, 2009

Dear Mr. Jansen

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 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 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.

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## Page 2- Mr. Richard Jansen, Pharm D.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Barbara Buchend

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 3. Statement of Indications for Use

510(k) Number (if known): (09116 19

Indications for Use:

The AngleFix T Locking Plate is indicated for temporary stabilization of long bone fractures including:

- Proximal and distal fractures including joint fractures of the humerus, tibia and . other long bones
- Metaphyseal, supracondylar, peri-articular, intra-articular, and intra-articular . condylar fractures
- Diaphyseal fractures .
- Ankle fractures .
- Simple, comminuted and depression fractures .
- Non-unions and malunions
- Osteotomies and bone reconstruction
- Fractures in normal or osteoporotic bone

Prescription Use 1 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Souita for mxm
(Division Sign O

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_K09) 6/9