(80 days)
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.
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
This document describes a 510(k) premarket notification for a medical device, specifically a new plate system (K012694- 2.4mm Variable Angle LCP Dorsal Distal Radius System) and an expansion of indications for existing plate systems.
Based on the provided text, the submission focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and does not involve AI/ML-driven performance acceptance criteria or studies as typically understood for software devices.
Therefore, most of the requested information regarding AI/ML-specific acceptance criteria, study design, expert involvement, and ground truth establishment is not applicable to this document. The study described is primarily a mechanical testing regimen.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: Features of subject components are substantially equivalent to predicate devices based on similarities in intended use and design. | "The features of the subject components are substantially equivalent to the predicate devices based on similarities in intended use and design." |
| Mechanical Strength: Mechanical testing demonstrates substantial equivalence of subject components to predicate devices in regards to mechanical strength. | "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate devise in regards to mechanical strength." |
| Material Equivalence: Made from stainless steel and commercially pure titanium, with comparable mechanical & functional properties to predicate devices. | "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." |
| Fatigue Strength: Assessment of the fatigue strength of the subject device, with finite element analysis determining the worst-case construct and dynamic loading testing confirming substantial equivalence to the predicate device construct. | "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." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of physical devices tested; however, the testing methodology involved "Finite Element Analysis" (FEA) to determine worst-case scenarios and "dynamic loading testing" to confirm equivalence. FEA is a computational method, and dynamic loading testing would involve physical specimens. The specific number of physical specimens is not provided.
- Data Provenance: Not applicable in the context of clinical data provenance. The data generated is from laboratory-based mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical device, and "ground truth" in this context refers to established engineering and material science principles and performance benchmarks for predicate devices, rather than expert interpretation of clinical data.
4. Adjudication method for the test set:
- Not applicable. The evaluation is based on objective mechanical testing results and comparison to predicate device performance. There is no human adjudication process described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This document pertains to a mechanical bone fixation system, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's evaluation is the established mechanical performance and material properties of the predicate devices, as determined through engineering and material science standards and testing. Finite Element Analysis (FEA) and dynamic loading testing are used to compare the new device to these established benchmarks.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The "training" in the engineering context would be the design and development process informed by engineering principles and previous device designs.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device with a training set and ground truth in the AI sense.
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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 ParkwayWest 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, HRSClass 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
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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
::
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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
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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
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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
·
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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
7/7
§ 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.