(90 days)
Not Found
No
The device description focuses on the physical components (plates, screws) and their materials and dimensions, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on mechanical testing standards (ASTM F382 and F543), not algorithmic performance metrics.
Yes
The device is described as providing fixation during fractures, fusions, and osteotomies for various parts of the pelvic region, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions, which indicates a therapeutic purpose.
No
Explanation: The device description states that the Acumed Pelvic Bone Plate System is designed to provide fixation during fractures, fusions, and osteotomies. This indicates a therapeutic or reconstructive purpose rather than a diagnostic one.
No
The device description explicitly details physical components such as plates, screws, and accessories made of titanium, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Acumed Pelvic Bone Plate System is a system of plates, screws, and accessories designed for surgical fixation of bones in the pelvic region. It is implanted directly into the body to stabilize fractures, fusions, and osteotomies.
- Intended Use: The intended use clearly states its purpose is for fixation during surgical procedures on the pelvic bones. It does not involve testing or analyzing biological specimens.
Therefore, based on the provided information, the Acumed Pelvic Bone Plate System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Acumed Pelvic Bone Plate System includes plates, screws, and accessories designed to provide fixation during fractures, fusions, and osteotomies for the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.
Plates are available in a variety of shapes and sizes which can be used "as is" or additionally contoured and/or trimmed intraoperatively to accommodate varying injury patterns and/or patient anatomy. All plates are made of titanium per ASTM F67 and are designed to accommodate the 3.5mm screws included in the system. Plates range in length from 30mm to 250mm, have a width of 4mm to 17mm, and a thickness of 1.5mm to 4mm.
The system includes 3 families of screws with different diameters: 2.7mm, 3.5mm, and 4.3mm. All screw families can be used for fixation independent of the plates. Screws are made of titanium alloy per ASTM F136.
All implants are provided sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
acetabulum, sacrum, ilium, and entire pelvic ring
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The non-clinical testing included in this submission includes testing to ASTM F382 and F543.
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.
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
510(k) Summary
Contact Details
Applicant Name: Acumed LLC 5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432
Kara Budor, Regulatory Specialist 503-207-1412
Date Prepared: August 20, 2012
Device Name
Trade Name: Acumed Pelvic Bone Plate System
Common Name: Pelvic System
Classification: 21 CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
Class: II
Product Code: HRS
Legally Marketed Predicate Device(s)
There are two predicate devices. The comparison is to the Stryker Trauma Pelvic Set and the I.T.S. Pelvic Reconstruction System.
| 510(k) Number | Product Code | Trade Name | Applicant |
|---|---|---|---|
| K001614 | KTW | ||
| 888.3030 | Stryker Trauma Pelvic Set | Howmedica Osteonics | |
| Corp. | |||
| K063166 | HRS | ||
| 888.3030 | I.T.S. Pelvic Reconstruction | ||
| System | I.T.S. Implantat- | ||
| Technologie-Systeme | |||
| GmbH |
Device Description
The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium,
1
and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.
Plates are available in a variety of shapes and sizes which can be used "as is" or additionally contoured and/or trimmed intraoperatively to accommodate varying injury patterns and/or patient anatomy. All plates are made of titanium per ASTM F67 and are designed to accommodate the 3.5mm screws included in the system. Plates range in length from 30mm to 250mm, have a width of 4mm to 17mm, and a thickness of 1.5mm to 4mm.
The system includes 3 families of screws with different diameters: 2.7mm, 3.5mm, and 4.3mm. All screw families can be used for fixation independent of the plates. Screws are made of titanium alloy per ASTM F136.
All implants are provided sterile and non-sterile.
Intended Use/Indications for use
The Acumed Pelvic Bone Plate System consists of plates, screws and accessories intended to provide fixation during fractures, fusions, and osteotomies of the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.
Substantial Equivalence Comparison
The basic comparison between the Acumed Pelvic Bone Plate System and the predicate devices is given in the table below.
| Category | Acumed Pelvic
Bone Plate System | I.T.S. Pelvic Reconstruc-
tion System K063166 | Stryker Trauma Pelvic Set
K001614 |
|------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Material | Titanium per ASTM F67
and Titanium alloy per
ASTM F136 | Commercially pure
titanium and 6-4 alloyed
titanium | Stainless Steel per ASTM
F138 |
| Plate Shape | Straight plates
Curved plates
Plates for anatomy specific
sites | Straight plates
Curved plates
Plates for anatomy specific
sites | Straight plates
Curved plates
Plates for anatomy specific
sites |
| Plate Fixation
Method | Screw fixation | Screw fixation | Screw fixation |
| Screw Type | Non-locking | Non-locking and Locking | Non-locking |
| Provided sterile
and/or non-
sterile | Provided sterile and non-
sterile | Unknown | Provided sterile and non-
sterile |
| Implants are
used with
general surgical
instrumentation | Yes | Yes | Yes |
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Acumed Pelvic Bone Plate System 510(k) Notification
The Acumed Pelvic Bone Plate System, the I.T.S. PRS Low Profile – Multiple Type – Pelvic Plating System, and the Stryker Trauma Pelvic Set are all systems of plates, screws, and instruments which are used to achieve fixation. There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Pelvic Bone Plate System is substantially equivalent to the predicate devices.
Non-clinical Testing
The non-clinical testing included in this submission includes testing to ASTM F382 and F543.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 19, 2012
Acumed, LLC % Ms. Kara Budor Regulatory Specialist 5885 Northwest Cornelius Pass Road Hillsboro, Oregon 97124
Re: K122538
Trade/Device Name: Acumed Pelvic Bone Plate 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: August 20, 2012 Received: August 21, 2012
Dear Ms. Budor: .
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
4
Page 2- Ms. Kara Budor
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htmfor 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 vours. Erin I. Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation · Center for Devices and Radiological Health
5
Acumed Pelvic Bone Plate System 510(k) Notification
Indications for Use
510(k) Number (if known): K122538
Device Name: Acumed Pelvic Bone Plate System
Indications for Use:
The Acumed Pelvic Bone Plate System includes plates, screws, and accessories designed to provide fixation during fractures, fusions, and osteotomies for the acetabulum, sacrum, ilium, and entire pelvic ring, as well as treatment of sacroiliac joint dislocations and symphysis pubis disruptions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21. CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) .
K. Ath
(Division Sign-Off) Division of Orthopedic Device 510(k) Number K12253
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