(80 days)
Not Found
No
The summary describes a system of plates and screws for bone fixation and does not mention any AI or ML components or functions.
No
This device is an implantable plate system used for fracture fixation, which is a structural support device rather than one that treats or prevents a disease or condition.
No
The device is a system of plates and screws intended for the fixation of bone fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical plates and screws made of stainless steel and titanium, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones." This describes a surgical implant used to stabilize bone fractures, not a device used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details plates and screws made of stainless steel and titanium, designed to be surgically implanted. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the 2.4 mm LCP Distal Radius System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The 2.4 mm LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. The dorsal plate has a pre-contoured design to fit along the dorsal radial column of the distal radius. These new plates incorporated variable angle locking technology. There are 6 different plate types and they are available in 316L stainless steel and CP -4 titanium. The plates are offered in 5 basic shapes: 2-hole L-plate, a 3-hole L-plate, straight (radial column) plates, oblique plates and T-plates. The L-plates, T-plates, and oblique plates come in 3- and 5-hole lengths. The straight (radial column) plates come in 5- and 6- hole lengths. The 2-Hole L-plate, a 3-hole L-plate, and oblique plates are also offered in left and right-angled configurations
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
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)
Testing conducted to support the substantial equivalence of the 2.4mm VA- LCP Dorsal Distal Radius System was aimed to assess the fatigue strength of the subject device. Finite Element Analysis was used to determine the worst case construct and dynamic loading testing was used to confirm that the subject device construct is substantially equivalent to the predicate device construct.
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.
K012114, K982732, K023879, K071184
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 shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a person. The logo is also in black and is enclosed in a circle. A registered trademark symbol is located to the right of the word.
.K10269 4
DEC 9 . 2010
4.0 510(k) Summary
l
Page 1 of 2
Prepared: November 11, 2010
Purpose for Submission: To introduce a new plate system (K012694- 2.4mm Variable Angle LCP Dorsal Distal Radius System) into interstate commerce and to expand the indications of existing plate systems (K091644, K083694, K092556, K012114, K071184 and K031725) to include "skeletally mature adolescents and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intraarticular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius."
Bundled Plate Systems (for Pediatric Indication):
K091644 - 2.4mm LCP Volar Distal Radius Plates K083694 - 2.4mm Variable Angle LCP Two-Column Volar Distal Radius Plates K092556 - 2.4mm Variable Angle LCP Two-Column Narrow Volar Distal Radius Plates K071184 - Variable Angle LCP Distal Radius System K012114 - Synthes Locking Distal Radius Plating System K031725 - Synthes Ti-15Mo Locking Distal Radius Plating System
| Sponsor: | Synthes (USA)
Christopher Hack, Esq.
1301 Goshen Parkway
West Chester, PA 19380
(610) 719-6940 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | 2.4mm Variable Angle LCP Dorsal Distal Radius System |
| Classification: | Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories, HRS
Class II, §888.3040 - Smooth or threaded metallic bone fixation fastener |
| Predicate Device: | Synthes Locking Distal Radius Plating System - (K012114)
Synthes Distal Radius Plate System - (K982732)
Synthes Small Titanium Wrist Fusion Plate - (K023879)
Synthes Variable Angle Locking Compression Plate - (K071184) |
| Device Description: | The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. The dorsal plate has a pre-contoured design to fit along the dorsal radial column of the distal radius. These new plates incorporated variable angle locking technology. There are 6 different plate types and they are available in 316L stainless steel and CP -4 titanium. The plates are offered in 5 basic shapes: 2-hole L-plate, a 3-hole L-plate, straight (radial column) plates, oblique plates and T-plates. The L-plates, T-plates, and oblique plates come in 3- and 5-hole lengths. The straight (radial column) plates come in 5- and 6- hole lengths. The 2-Hole L-plate, a 3-hole L-plate, and oblique plates are also offered in left and right-angled configurations |
| Intended Use: | The 2.4 mm LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, |
. .
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Image /page/1/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. To the right of the word is a small circle with an R inside, indicating a registered trademark.
Substantial Equivalence: physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
2.62
The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design. Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength. In addition, the intended use, manufacturing methods, packaging, and sterilization of the predicate and subject components are identical.
The subject and predicate devices are made from stainless steel and commercially pure titanium. Functional and mechanical testing demonstrates the comparable mechanical & functional properties of the subject 2.4mm VA-LCP Dorsal Distal Radius System to the predicate devices.
Testing conducted to support the substantial equivalence of the 2.4mm VA- LCP Dorsal Distal Radius System was aimed to assess the fatigue strength of the subject device. Finite Element Analysis was used to determine the worst case construct and dynamic loading testing was used to confirm that the subject device construct is substantially equivalent to the predicate device construct.
Image /page/1/Picture/8 description: The image shows the word "CONFIDENTIAL" in bold, uppercase letters. The word is slightly distorted, with some blurring and pixelation, but the letters are still legible. The background is a light color, which contrasts with the dark letters.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized eagle emblem, depicted with three curved lines representing the eagle's body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Synthes (USA) Christopher Hack, Esq., Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
DEC - 9 2010
Re: K102694
Trade/Device Name: Synthes 2.4mm Variable Angle LCP Dorsal Distal Radius Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: November 11, 2010 Received: November 15, 2010
Dear Mr. Hack:
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
3
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.
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.
Az. B. r. be
bi.
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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510(k) Number (if known): K102694 Synthes (USA) 2.4mm Variable Angle LCP Dorsal Distal Radius Plates Device Name:
Indications for Use:
DEC - 9 2010
117
The 2.4 mm Variable Angle LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
...
!!
...
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Uxu
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102694
CONFIDENTIAL
::
5
Image /page/5/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with the registered trademark symbol is located to the right of the word.
510(k) Number (if known):
K10 269
Device Name:
RESERVED
Synthes (USA) 2.4mm LCP Volar Distal Radius Plates
Indications for Use:
The 2.4 mm LCP Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
...
:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar MKM
(Division Sign-Off) Forision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102694
CONFIDENTIAL
9 2
6
Image /page/6/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a figure inside. To the right of the word is a small circle with a degree symbol, indicating that the word is a registered trademark. The word is written in a sans-serif font.
510(k) Number (if known):
Device Name:
Synthes (USA) 2.4mm Variable Angle LCP Two-Column Volar Distal Radius Plates
Indications for Use:
The 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
Prescription Use (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
...
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
On for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
102694 510(k) Number
93
7
Image /page/7/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A small circle with a registered trademark symbol is located to the upper right of the word.
510(k) Number (if known):
K102 KOSTASSE
Device Name:
Synthes (USA) 2.4mm Variable Angle LCP Two-Column Narrow Volar Distal Radius Plates
Indications for Use:
The 2.4mm Variable Angle LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
..............................................................................................................................................................................
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for nxm
(Division/Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
CONFIDENTIAL
ps 41-
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Image /page/8/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. The logo appears to be a stylized representation of a medical device or implant. A small circle with a dot in the center is located to the right of the word "SYNTHES".
510(k) Number (if known):
Device Name:
Synthes (USA) Variable Angle LCP Distal Radius System
Indications for Use:
The Variable Angle LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
AND/OR
| Over-The-Counter Use
| (21 CFR 807 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
i(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
NxM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
CONFIDENTIAL
·
9
Image /page/9/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A small circle with an R inside is to the right of the word.
510(k) Number (if known):
K1026
Device Name:
Synthes (USA) Locking Distal Radius Plating System
Indications for Use:
The Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for nxra
(Division Sign-Off) Pivision of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102694
CONFIDENTIAL
10
510(k) Number (if known):
Device Name: Synthes (USA) Ti-15Mo Locking Distal Radius Plating System
Indications for Use:
The Ti-15Mo Locking Distal Radius Plating System Distal System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
. .
- : - - --
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for MXM
(Division Sign-Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102694
CONFIDENTIAL
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