(59 days)
No
The summary describes a system of bone plates and screws for fracture fixation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing, MR compatibility, sterilization, and biological safety, which are standard evaluations for orthopedic implants.
Yes
The device is indicated for the treatment of fractures and re-attachment of structures, which are therapeutic interventions.
No
This device is a plating system indicated for the treatment and stabilization of periprosthetic fractures and non-unions, acting as an implant to fix bones, not to diagnose a condition.
No
The device description clearly states it consists of "Stainless Steel Plates" and other physical components like screws and cables, which are hardware. The performance studies also focus on mechanical testing and material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the treatment of bone fractures and non-unions in the femur, tibia, and humerus. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a plating system made of stainless steel, designed to be implanted to stabilize fractures. This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- No mention of in vitro testing: There is no mention of the device being used to test samples like blood, urine, or tissue outside of the body.
- Performance Studies: The performance studies focus on mechanical testing, magnetic resonance compatibility, sterilization, shelf life, and biological safety – all relevant to an implantable medical device, not an IVD.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone.
DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus.
DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles.
DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.
DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System of Stainless Steel Plates for periprosthetic fractures. It consists of plates that offer screw to plate non-locking constructs, locking constructs or a combination of both. The plates accept commercially available DePuy Synthes Stainless Steel 3.5 mm cortex screws, 3.5 mm (variable angle) locking screws, 4.5 mm cortex screws and 5.0 mm (variable angle) locking screws, as well as the Synthes Orthopaedic Cable system.
The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System offers:
- 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates
- 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plates
- 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plate
- 3.5 mm VA Locking PPFx Greater Trochanter Hook Plate
- 3.5 mm VA Locking PPFx Greater Trochanter Ring Attachment Plate
- 3.5 mm VA Locking Attachment Plate
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia, humerus
Indicated Patient Age Range
adult patients
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)
Mechanical testing of a broad range of possible constructs (plates with screws) under static and dynamic loading conditions have been performed to compare the proposed DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System to the predicate device. The standards used to develop and perform mechanical testing are ASTM F382:2017, ASTM STP 731:1981 and ISO 12107-2nd Ed. The results of this testing support that the mechanical performance of the subject devices is non-inferior to that of the predicate device.
Magnetic Resonance compatibility testing has been performed to establish MR Conditional parameters for the subject DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System. The standards used to develop and perform Magnetic Resonance compatibility testing are ASTM F2052:2015, ASTM F2119:07(2013), ASTM F2182:19e2, ASTM F2213:2017 and ASTM F2503:2013
The devices in DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System are provided both sterile and non-sterile. The validations for sterile devices are performed in accordance with ANSI/AAMI/ISO 11137:2015 demonstrating a Sterility Assurance Level (SAL) of 10-6 when sterilized utilizing gamma radiation.
The sterile packaging shelf life of the DePuy Synthes Periprosthetic Proximal Femur Plating implants has been validated to be ten years when tested in accordance with ISO 11607-1:2020 “Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems” and ISO 11607-2:2020 “Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes.”
Biological safety evaluation for the devices in DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System was performed in accordance with ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process” and FDA guidance 'Use of International Standard ISO 10993-1,
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K041911, K082807, K092609, K000682, K032032, K001709
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized depiction of human figures. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
March 26, 2021
Synthes (USA) products, LLC Satapa Dhamankar Senior Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K210205
Trade/Device Name: DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates, DePuv Synthes 3.5 mm VA Locking Attachment Plate, DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates, DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates, DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook 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: January 25, 2021
Received: January 26, 2021
Dear Satapa Dhamankar:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Indications for Use (Describe)
DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone.
DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus.
DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles.
DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.
DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K210205
| Sponsor | DePuy Synthes
Satapa Dhamankar
1301 Goshen Parkway
West Chester, PA 19380
Phone: +1 610 719 6574 |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date prepared | March 23, 2021 |
| Proprietary name | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal
Femur Plating System |
| Classification name | Single/multiple component metallic bone fixation appliances and
accessories |
| Classification | Class II
Regulation Number: 21 CFR 888.3030
Product Code: HRS
Common Name: Plate, Fixation, Bone |
| Predicate device | Primary predicate:
• Synthes Locking Attachment Plate (K083573)
Additional/Reference predicates:
• Synthes LCP Straight and Curved Plates (K041911, K082807,
K092609, K000682)
• 4.5 mm LCP Proximal Femur Hook Plate (K032032)
• Trochanteric Reattachment Device (K001709) |
| Device description | The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic
Proximal Femur Plating System of Stainless Steel Plates for periprosthetic
fractures. It consists of plates that offer screw to plate non-locking
constructs, locking constructs or a combination of both. The plates accept
commercially available DePuy Synthes Stainless Steel 3.5 mm cortex
screws, 3.5 mm (variable angle) locking screws, 4.5 mm cortex screws and
5.0 mm (variable angle) locking screws, as well as the Synthes
Orthopaedic Cable system.
The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic
Proximal Femur Plating System offers:
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plates
• 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Hook Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Ring Attachment Plate
• 3.5 mm VA Locking Attachment Plate |
| Indications for use | DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and
Proximal Femur Hook Plates are indicated for the treatment of
periprosthetic fractures and fractures in the presence of intramedullary
implants in the proximal end segment and the proximal and middle 1/3
of the diaphyseal segment of the femur, and non-unions or malunions
of such fractures, in adult patients, particularly in osteoporotic and
osteopenic bone. |
| | DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to
augment the stabilization of fractures, including periprosthetic fractures
(Vancouver Type B when used with either the 3.5 mm/4.5 mm VA-LCP
PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver
Type B and C when used with other DePuy Synthes LCP plates and VA-
LCP plates) and fractures in the presence of intramedullary implants, in
the femur, tibia, and humerus. |
| | DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning
Attachment Plates (when used with either the 3.5 mm/4.5 mm VA-LCP
PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be
used to extend the length of a plate construct to the lateral condyles. |
| | DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring
Attachment Plates (when used with the 3.5 mm/4.5 mm VA-LCP PPFx
Proximal Femur Plate) are indicated for fixation or re-attachment of the
greater trochanter following fracture or osteotomy. |
| | DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates
are indicated for fixation or re-attachment of the greater trochanter
following fracture or osteotomy. |
| Contraindications | The DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur
Plating System is contraindicated if the hip stem is loose, which requires
immediate revision. |
| | The DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate
with 2-holes (shortest plate) is contraindicated for diaphyseal
periprosthetic femoral fractures where distal fixation of the construct is
not achievable. |
| | The DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook
Plate with 5 holes (shortest plate) is contraindicated for diaphyseal
periprosthetic femoral fractures where distal fixation of the construct is
not achievable. |
| | The DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning
Attachment Plates are contraindicated for spanning a fracture. |
| Comparison to
predicate | The subject device has the same intended use as the predicate device.
The indications of the subject system are a subset of the indications of
the predicate device. |
| | The subject devices and the predicate device are metallic plates of similar
design intended for bone fracture fixation. Both subject and predicate
devices are anatomically contoured plates. Both subject and predicate
devices have similar hole specifications and are compatible with the
same screw types. Both subject and predicate devices have similar
connection mechanisms for the attachment of modular plates. Both
subject and predicate devices are compatible with the Orthopaedic Cable
System (K992616). |
| | The subject devices present the following features that are not found in
the predicate device: |
| | Subject devices incorporate well known and commercially
available variable angle screw technology vs. the predicate
devices which utilize standard locking screws |
| | The subject system is a modular system, where multiple devices
can be used in combination with each other to address a variety
of surgeon / patient needs. |
| | Subject devices offer a higher density of variable angle locking
screw holes for additional fixation points |
| | The subject devices are made from Stainless Steel (316L), and the
predicate device is made from Stainless Steel (316L), Commercially Pure
Titanium (CPTi4) or Titanium Alloy (TAN). |
| | It can be concluded that the features of the subject device are
substantially equivalent to the predicate device based on the similarities
in intended use and design. |
| Non-clinical
performance data | The following performance data were provided in support of the
substantial equivalence |
| | Mechanical testing of a broad range of possible constructs (plates with
screws) under static and dynamic loading conditions have been
performed to compare the proposed DePuy Synthes 3.5/4.5 mm
Variable Angle LCP Periprosthetic Proximal Femur Plating System to the
predicate device. The standards used to develop and perform
mechanical testing are ASTM F382:2017, ASTM STP 731:1981 and ISO
12107-2nd Ed. The results of this testing support that the mechanical
performance of the subject devices is non-inferior to that of the
predicate device. |
| | Magnetic Resonance compatibility testing has been performed to
establish MR Conditional parameters for the subject DePuy Synthes |
| | 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating
System. The standards used to develop and perform Magnetic
Resonance compatibility testing are ASTM F2052:2015, ASTM
F2119:07(2013), ASTM F2182:19e2, ASTM F2213:2017 and ASTM
F2503:2013 |
| | The devices in DePuy Synthes 3.5/4.5 mm Variable Angle LCP
Periprosthetic Proximal Femur Plating System are provided both sterile
and non-sterile. The validations for sterile devices are performed in
accordance with ANSI/AAMI/ISO 11137:2015 demonstrating a Sterility
Assurance Level (SAL) of 10-6 when sterilized utilizing gamma radiation. |
| | The sterile packaging shelf life of the DePuy Synthes Periprosthetic
Proximal Femur Plating implants has been validated to be ten years
when tested in accordance with ISO 11607-1:2020 “Packaging for
terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems” and ISO
11607-2:2020 “Packaging for terminally sterilized medical devices —
Part 2: Validation requirements for forming, sealing and assembly
processes.” |
| | Biological safety evaluation for the devices in DePuy Synthes 3.5/4.5
mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
was performed in accordance with ISO 10993-1:2018 Biological
evaluation of medical devices Part 1: Evaluation and testing within a risk
management process” and FDA guidance 'Use of International Standard
ISO 10993-1, |
| It is concluded that the information provided herein supports | |
| substantial equivalence of the subject devices. | |
4
5
6
7