(90 days)
No
The device description focuses on the mechanical design and materials of the plates and screws, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical and material testing, not related to algorithmic performance.
Yes
The device is an implantable plate system designed to treat fractures, which is a therapeutic intervention.
No.
The device is a surgical implant designed to treat fractures of the acetabulum, not to diagnose a condition.
No
The device description clearly outlines physical implants (plates and screws) made of Stainless Steel, intended for surgical implantation. This is a hardware medical device, 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 treatment of fractures of the acetabulum. This is a surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as plates and screws used for fixing bone fractures. This is a physical implant, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing diagnostic information.
In summary, the DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are a surgical implant used for bone fixation, which falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greater than 12 through 21 years of age) where all growth plates within the acetabulum are fused.
Product codes
HRS
Device Description
The DePuy Synthes 3.5 mm Intrapelvic Acetabular System can be used to treat fractures of the acetabulum involving the anterior column, with or without involvement of the posterior column, including the quadrilateral surface (QS). The subject system is comprised of four plate types per anatomic side, left and right, (Large Extended, Small Extended, Large Standard and Small Standard) which are designed to accept the following existing cortex screws: 3.5 mm Cortex Screws, 3.5 mm Pelvic Cortex Screws, 3.5 mm Cortex Screws with low-profile head, 3.5 mm Stardrive Cortex Screws, and 4.5 mm Cortex Screws. The implants are available in a sterile configuration and are offered in Stainless Steel (SSt). In total the system is comprised of eight different plate designs. Each plate configuration consists of a long, slender suprapectineal portion that is intended to be placed along the anterior column, superior to the pelvic brim and a trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspect of the posterior column, overlapping at least a portion of the quadrilateral surface. The suprapectineal portion is divided into anterior and posterior segments that are configured to mimic existing 3.5 mm reconstruction plates and a central segment, to which the quadrilateral surface portion is connected by two connecting bars.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabulum
Indicated Patient Age Range
adults and adolescents (greater than 12 through 21 years of age) where all growth plates within the acetabulum are fused.
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
Mechanical testing of a worst-case construct under static and dynamic physiologic loading conditions have been performed to compare the proposed DePuy Synthes 3.5 mm Acetabular Plates to the predicate device. The results of this testing support that the mechanical performance of the subject device 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 mm Intrapelvic Acetabular System.
Endotoxin testing has been performed using the LAL test method to establish that the subject DePuy Synthes 3.5 mm Acetabular System meets the specified endotoxin requirement of 20 EU/device.
Clinical testing was not necessary for the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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
September 20, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
DePuy Synthes Alyssa Bryan Regulatory Affairs Specialist I 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K221809
Trade/Device Name: DePuy Synthes 3.5mm Intrapelvic Acetabular System 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: June 21, 2022 Received: June 22, 2022
Dear Alyssa Bryan:
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 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
1
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 mediation-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/cdrl-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, MPH 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) K221809
Device Name
DePuy Synthes 3.5 mm Intrapelvic Acetabular System
Indications for Use (Describe)
The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greather than 12 through 21 years of age) where within the acetabulum are fused.
| 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
K221809 - 510(k) Summary
| Sponsor | DePuy Synthes
Alyssa Bryan
1301 Goshen Parkway
West Chester, PA 19380
Phone: +41 61 965 63 14 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | August 18, 2022 |
| Proprietary Name | DePuy Synthes 3.5 mm Intrapelvic Acetabular System |
| Classification
Name | Single/multiple component metallic bone fixation appliances and accessories |
| Classification | Class II
Regulation Number: 21 CFR 888.3030
Product Code: HRS |
| Predicate devices | Primary Predicate:
Synthes (USA) Low Profile Reconstruction Plates
K042377
3.5 mm Wide Angle Low Profile Reconstruction Plates 3.5 mm Low Profile Reconstruction J-Plates (non-locking) |
| | Additional Predicate:
Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate
K031573
3.5 mm Low Profile Reconstruction Plates 3.5 mm Low Profile Curved Reconstruction Plates (radius 108 mm) 3.5 mm Low Profile Curved Reconstruction Plates (radius 88 mm) |
| Device Description | The DePuy Synthes 3.5 mm Intrapelvic Acetabular System can be used to treat fractures of the
acetabulum involving the anterior column, with or without involvement of the posterior column,
including the quadrilateral surface (QS). The subject system is comprised of four plate types
per anatomic side, left and right, (Large Extended, Small Extended, Large Standard and Small
Standard) which are designed to accept the following existing cortex screws: 3.5 mm Cortex
Screws, 3.5 mm Pelvic Cortex Screws, 3.5 mm Cortex Screws with low-profile head, 3.5 mm
Stardrive Cortex Screws, and 4.5 mm Cortex Screws. The implants are available in a sterile
configuration and are offered in Stainless Steel (SSt). In total the system is comprised of eight
different plate designs. Each plate configuration consists of a long, slender suprapectineal
portion that is intended to be placed along the anterior column, superior to the pelvic brim and
a trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspect
of the posterior column, overlapping at least a portion of the quadrilateral surface. The
suprapectineal portion is divided into anterior and posterior segments that are configured to
mimic existing 3.5 mm reconstruction plates and a central segment, to which the quadrilateral
surface portion is connected by two connecting bars. |
| Indications for use | The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the
acetabulum in adults and adolescents (greater than 12 through 21 years of age) where all
growth plates within the acetabulum are fused. |
| Contraindications | Not intended for patients with active growth plates. |
| 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. |
| | Additional features are found in the subject Acetabular Plates that are not found in the predicate
Low Profile Reconstruction Plates. However, these features do not alter the fundamental
technology of the device and therefore do not raise new issues of safety and effectiveness: |
| | Trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspect of the posterior column overlapping at least a portion of the quadrilateral surface |
| | Non-locking screw holes on the quadrilateral surface portion designed to target bone in the sciatic buttress |
| | A non-locking oblique screw hole in the distal portion of the quadrilateral surface designed to target screw anchorage within the ischium while avoiding the acetabulum Additional holes to facilitate plate placement with instrumentation as well as in-situ and ex-situ contouring |
| | |
| | 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 | Mechanical testing of a worst-case construct under static and dynamic physiologic loading
conditions have been performed to compare the proposed DePuy Synthes 3.5 mm Acetabular
Plates to the predicate device. The results of this testing support that the mechanical
performance of the subject device 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 mm Intrapelvic Acetabular System. |
| | Endotoxin testing has been performed using the LAL test method to establish that the subject
DePuy Synthes 3.5 mm Acetabular System meets the specified endotoxin requirement of
20 EU/device. |
| Clinical
Performance Data | Clinical testing was not necessary for the determination of substantial equivalence. |
| Substantial
Equivalence | The subject device has the same intended use compared to the predicate device. |
| | The non-clinical performance data as well as the comparison of design features included in
this premarket notification demonstrate that any differences in technological characteristics of
the subject device compared to the predicate device do not raise any new issues related to
mechanical performance, safety or efficacy and can be labeled MR Conditional. The proposed
devices are at least as safe and effective as the predicate devices |
| | It is concluded that the information provided herein supports substantial equivalence of the
subject devices. |
4