(87 days)
Not Found
No
The device description focuses on the physical components and their intended use for fracture fixation, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for "fixation of fractures" and "healing of comminuted bone fragments," which are therapeutic actions.
No
Explanation: The device is described as an "INTERNAL FIXATION SYSTEM" intended for "fixation of fractures" to various bones. Its components (plates, screws, pins, wires) are used to hold bones together for healing, which is a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly outlines physical components such as plates, screws, pins, and wires, which are hardware implants for internal fixation. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for "fixation of fractures to the various bones." This is a surgical procedure performed directly on the patient's body to stabilize broken bones.
- Device Description: The description details implants like plates, screws, pins, and wires, which are all designed to be surgically implanted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE.
The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges).
The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
Pin and Wire are indicated for use in fracture fixation, for healing of comminuted bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
Product codes
HRS, KTT, HWC
Device Description
The KENS INTERNAL FIXATION SYSTEM consists of NON-STERILE plate, screw, pins, wires and DHS/DCS plate systems. The plates are devices, which are fastened by screws to bone for the purpose of providing fixation. According functional differences, plates are gathered in four kinds: Dynamic Compression Plate (DCP), tubular, special and DHS/DCS. The shape of the plate is designed to an adaptation of the local bone anatomy and doesn't denote any particular function. KENS plates are divided as the following:
DCP: Narrow, Broad, Broad Limited, Narrow Limited, Lengthening-Narrow, Lengthening Broad, Straight,
Tubular: Semi-tubular, one-third, quarter
Special: T-shaped, T-Buttress, T-Oblique, L-shaped, L-buttress, Cobra Head, Lateral tibial head, Condylar Buttress, Spoon, Reconstruction, Reconstruction-curved, Hook, H-shaped, W-shaped, Cloverleaf, Calcaneal, Y-Calcaneal, Adaptation, Compression, Multiple Fragment Plate, Condylar
DHS/DCS: Dynamic Hip Screw, Dynamic Condylar Screw
KENS screws & plates are grouped in 3 subsystems: mini fragment, small fragment and basic (also known as large fragment). The size range of plates are in thickness from 1.0 to 6.0mm, width from 3.8 to 17mm, length 17 to 370mm. and hole number from 2 to 22 holes. The size ranges of screw are in thread diameter from 1.5 to 7.0 mm. total length from 6 to 180mm. In which the screws are differentiated in 5 main kinds of: cortex, cancellous, malleolar, shaft and cannulated screws.
The DHS/ DCS plate system consists of DHS/DCS Plate, Lag Screw, DHS/DCS Compression Screw and 4.5mm Cortex Screw. The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95°, 135°, 140°, 145° and 150°. The self-tapping 4.5mm Cortex Screw can also be used to fix the DHS/DCS Plate to the femoral shaft. The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter from 12.5 to 14mm.
The DHS/DCS Compression Screw with buttress thread, length 26mm and outer diameter 4.0mm, can be used to achieve fracture compression.
Pins and wires are divided into groups of:
- Kirschner wires are in length from 100 to 300mm and range in diameter is under 3.0mm and are available with trocar or diamond tip.
- Steinmann pin are in diameter 2.0~5.0mm and range in length from 125 to 300mm and are available with trocar or diamond tip.
- Schanz pins are supplied in diameter 1.25 ~6.0 and range in length from 80mm to 300mm.
- Knowles pins are with square and hexagonal drive, a break off length ranges from 63.5 to 152.4mm, and a thread diameter 4.0 & 4.8mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle, pelvis, scapula, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), small bone (metacarplas, metatarsals, and phalanges), 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)
Instruction for Use and Labeling were given to understand the safety purposed all these instruction for use prior to clinical use and the results of laboratory (nonclinical) performance testing demonstrate that the devices are safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
INTAI bone plates and bone screw system & INTAI DHS/DCS plate system (K063020)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K090786 (pg. 1 of 3)
ens FineMedTech san. Bhd.(769476-0)
Formerly known as Bigeast Technologies Sdn. Bhd.)
510 {k} Summary of Safety and Effectiveness
JUN 18 2009
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CRF 807.92.
Company
Kens FineMedTech Sdn.Bhd 19, Free Industrial Zone, Phase 4, Bayan Lepas, 11900 Penang. Malaysia Tel : (604)6161356 / 6161357 Fax : ( 604) 6161353
Contact Person
Registration Number
Prepared Date
Proprietary Name
Common Name
Reviewing Panel
Classification Name
Device Code
Predicate devices:
Material:
Leow Kok Hooi (General Manager)
769476-U
01/05/2009
KENS INTERNAL FIXATION SYSTEM
Bone Plate, Bone Screw , Pin and Wire
Orthopedic
Class II , . CFR 888.3030 Single/Multiple Component Metallic Bone Fixation Appliances and Accessories
Class II, ●CFR 888.3040 Smooth or Threaded metallic Bone Fixation Fastener
Class II, •CFR 888.3030 Appliance fixation, nail/blade/plate combination, multiple component
HRS, HWC, KTT
INTAI Technology Corp., INTAI bone plates and bone screw system & INTAI DHS/DCS plate system (K063020)
10 Lilir Cunani Kaluana 7 Toman Dorinductrian Royan Longo Enen IV 14000 Dor
1
K090786 (pg. 2 of 3)
Kens FineMedTech sdn. Bhd. (769476-0)
(Formerly known as Bigeast Technologies Sdn. Bhd.)
The devices are manufactured from medical grade 316L stainless steel and Titanium that meets ASTM F138-08, ASTM F139-08, Titanium alloy ASTM F136-02a. and Pure Titanium ASTM F67-06.
Indication for Use:
The devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE.
The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges).
The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
Pin and Wire are indicated for use in fracture fixation, for healing of comminuted bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
Description of Device:
The KENS INTERNAL FIXATION SYSTEM consists of NON-STERILE plate, screw, pins, wires and DHS/DCS plate systems. The plates are devices, which are fastened by screws to bone for the purpose of providing fixation. According functional differences, plates are gathered in four kinds: Dynamic Compression Plate (DCP), tubular, special and DHS/DCS. The shape of the plate is designed to an adaptation of the local bone anatomy and doesn't denote any particular function. KENS plates are divided as the following:
| Product Name | Geometry Shape |
|---|---|
| DCP | Narrow, Broad, Broad Limited, Narrow Limited, |
| Lengthening-Narrow, Lengthening Broad, Straight, | |
| Tubular | Semi-tubular, one-third, quarter |
| Special | T-shaped, T-Buttress, T-Oblique, L-shaped, L-buttress, |
| Cobra Head, Lateral tibial head, Condylar Buttress, Spoon, | |
| Reconstruction, Reconstruction-curved, Hook, H-shaped, | |
| W-shaped, Cloverleaf, Calcaneal, Y-Calcaneal, Adaptation, | |
| Compression, Multiple Fragment Plate, Condylar | |
| DHS/DCS | Dynamic Hip Screw, Dynamic Condylar Screw |
KENS screws & plates are grouped in 3 subsystems: mini fragment, small fragment and basic (also known as large fragment). The size range of plates are
aai Kaluana 7 Taman Darinductrian Ravan Lanac Faca IV 11000 Panana Malaveia
2
2
K090786 (pg. 3 of 3)
Image /page/2/Picture/1 description: The image shows a logo that consists of a circle and three horizontal lines. The circle is not fully closed, with a gap on the right side. The three horizontal lines are stacked vertically, and they are connected to the circle on the right side. The logo has a rough, textured appearance, as if it were drawn with a thick marker or pen.
ens FineMedTech san. Bhd.(769476-U) Formerly known as Bigeast Technologies Sdn. Bhd.)
in thickness from 1.0 to 6.0mm, width from 3.8 to 17mm, length 17 to 370mm. and hole number from 2 to 22 holes. The size ranges of screw are in thread diameter from 1.5 to 7.0 mm. total length from 6 to 180mm. In which the screws are differentiated in 5 main kinds of: cortex, cancellous, malleolar, shaft and cannulated screws.
The DHS/ DCS plate system consists of DHS/DCS Plate, Lag Screw, DHS/DCS Compression Screw and 4.5mm Cortex Screw. The DHS Plates are available with short and standard barrel which length is 25mm and 38mm respectively. And the barrel angles are available in 95°, 135°, 140°, 145° and 150°. The self-tapping 4.5mm Cortex Screw can also be used to fix the DHS/DCS Plate to the femoral shaft. The DHS/DCS Screw is available in total length from 50 to 145 mm, thread length 22mm, shaft diameter 7.9mm, and outer diameter from 12.5 to 14mm.
The DHS/DCS Compression Screw with buttress thread, length 26mm and outer diameter 4.0mm, can be used to achieve fracture compression.
Pins and wires are divided into groups of:
- . Kirschner wires are in length from 100 to 300mm and range in diameter is under 3.0mm and are available with trocar or diamond tip.
- Steinmann pin are in diameter 2.0~5.0mm and range in length from 125 to 300mm and are available with trocar or diamond tip.
- . Schanz pins are supplied in diameter 1.25 ~6.0 and range in length from 80mm to 300mm.
- Knowles pins are with square and hexagonal drive, a break off length ranges from 63.5 to 152.4mm, and a thread diameter 4.0 & 4.8mm.
Substantial Equivalence:
The KENS Internal Fixation System has the same intended us, has similar performance characteristics, is manufactured from similar materials using similar processes, and is similar in design to the predicate devices of INTAI bone plates and bone screw system & INTAI DHS/DCS plate system (K063020).
Performance Data:
Instruction for Use and Labeling were given to understand the safety purposed all these instruction for use prior to clinical use and the results of laboratory (nonclinical) performance testing demonstrate that the devices are safe and effective.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
JUN 18 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Kens FineMedTech Sdn.Bhd. % Mr. Leow Kok Hooi General Manager 19, Free Industrial Zone Phase 4, Bayan Lepas, 11900 Penang, Malaysia
Re: K090786
Trade/Device Name: Kens Internal Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories.
Regulatory Class: Class II Product Codes: HRS, KTT, HWC Dated: February 21, 2009 Received: March 23, 2009
Dear Mr. Hooi:
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.
4
Page 2-Mr. Hooi
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 (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Nichols
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K096786
Device Name: KENS INTERNAL FIXATION SYSTEM
Indications for Use:
The devices of KENS INTERNAL FIXATION SYSTEM are provided NON-STERILE.
The Bone Plate, Bone Screw is intended for use in fixation of fractures to the various bones, including the clavicle, pelvis, scapula, calcaneus, long bone ( humerus, ulna, radius, femur, tibia, and fibula), an small bone ( metacarplas, metatarsals, and phalanges).
The DHS/DCS Plate System is intended for use in fixation of fractures to the proximal femur. The system is indicated for use in trochanteric, pertrochanteric, intertrochanteric, and basilar neck fractures.
Pin and Wire are indicated for use in fracture fixation, for healing of comminuted bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
X Prescription Use (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)
| (Division Sign-Off) | Page 1 of 1 |
|---|---|
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K090786 |