(85 days)
Not Found
No
The 510(k) summary describes various orthopedic implants and accessories. The only change mentioned is the sterilization of existing products. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device consists of various plates, screws, and beads intended to aid in the healing and fixation of fractures, reconstruct ligaments, and perform osteotomies. These are all interventions for medical conditions, classifying them as therapeutic.
No
Explanation: The document describes various orthopedic implants (plates, screws, tension bands, suture beads) used for aiding the healing of fractures, fixating soft tissue grafts, and osteotomies. These are therapeutic devices, not diagnostic devices.
No
The device description and intended use clearly describe physical implants (plates, screws, wire, beads) used for fracture fixation and soft tissue repair. The only change mentioned is the sterilization of these physical devices. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description and intended use clearly state that these devices are implants (plates, screws, wires, beads) used for the fixation and repair of bones, ligaments, and tendons within the human body. They are surgical implants, not devices used to test specimens outside the body.
The fact that the devices are now provided sterile is a change in manufacturing or packaging, but it does not change their fundamental nature as surgical implants used in vivo.
N/A
Intended Use / Indications for Use
The indications for use for each product cleared under 510(K) remains the same. The only difference in the product is that it will now be available sterile.
Small Fragment Plates and Screws: Used as an aid to the healing of volar rim fractures of the distal radius.
Device Name: Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically:
- Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone.
- An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.
- A combination of the above
Tension Band Wire: Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of the injury.
TriMed Bearing Plate: TriMed Volar Bearing Plate:
- Fixation of fractures or non-unions of the distal radius
- Osteotomies of the distal radius to correct malunion.
The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
TriMed Bone Plates: The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
TriMed Tenodesis Cross Screw and Interference Screw: The TriMed Tenodesis Cross Screw and Interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include:
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon Transfer in the hand and wrist.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruciton, Tendon Transfers in the foot and ankle.
TriMed Suture Bead: The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment. The TriMed Suture Bead is not indicated for use within intra-articular sites.
Product codes (comma separated list FDA assigned to the subject device)
HRS, JDS, HWC, NDL, HTY, MBI
Device Description
The products cleared in the 510(K)'s listed above will now be provided sterile by TriMed, Inc. No other changes have been made to the devices. Sterilization, packaging, aging and shipping validations have proven that the product can reach the end user while maintaining a sterility assurance level of 10-6.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Distal radius, olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, proximal humerus, ulna, Tibia, Fibula, Ulna, Radius, Humerus, Hand/Wrist: Scapholunate, Ulnar collateral, Radial Collateral, Carpometacarpal joint, Carpal, Tendon; Foot/Ankle: Lateral, Medial, Achilles Tendon, Hallux Valgus, Midfoot, Metatarsal Ligament, Flexor Hallucis Longus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
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.
Not Found
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.
K951302, K951303, K010545, K040112, K043263, K060041, K081348
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
K091156 (pg. 1 of 2)
JUL 1 5 2009
510(K) Summary of Safety and Effectiveness TRIMED STERILE PRODUCT
Submitted By:
Registration #:
Prepared By/Contact Person:
Proprietary Name:
Classification:
510(K)'s Being Modified:
TriMed, Inc. 25864 Tournament Road, Ste. A Valencia, CA 91355 (800)633-7221
2031009
Kelli Anderson Phone: (661)312-7150 Fax: (661)254-8485
TriMed Sterile Product
Class II: Screw, Fixation, Bone HWC - Section 888,3040 Class II: Plate, Fixation, Bone HRS - Section 888.3030 Class II: Pin, Fixation, Smooth, Metallic NDL - Section 888.3040 Class II: Nail, Fixation, Bone JDS - Section 888.3030 Class II: Fastener, Fixation, Nondegradable, Soft Tissue MBI - Section 888.3040 Class II: Pin, Fixation, Smooth HTY - Section 888.3040
K951302 - TriMed, Inc. (Formerly MEDPAC) Small Fragment Plates & Screws K951303 - TriMed, Inc. (Formerly MEDPAC) SFC K010545 - TriMed, Inc. TBW
1 of 2
1
510(K)'s Being Modified (cont'd):
K040112 - TriMed, Inc. Bearing & Volar Bearing Plate K043263 - TriMed, Inc. Osteotomy Plate K060041 - TriMed, Inc. Bone Plates K081348 - TriMed, Inc. Tenodesis Cross Screw, Interference Screw, Suture Bead
IV. Indications For Use:
The indications for use for each product cleared under 510(K) remains the same. The only difference in the product is that it will now be available sterile.
II. Device Description:
The products cleared in the 510(K)'s listed above will now be provided sterile by TriMed, Inc. No other changes have been made to the devices. Sterilization, packaging, aging and shipping validations have proven that the product can reach the end user while maintaining a sterility assurance level of 10-6.
Cuih
Kelli Anderson, M.S., RAC Regulatory Affairs Specialist
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an eagle-like emblem with three horizontal bars extending from its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
TriMed, Inc. % OrthoCompliance Ms. Kelli Anderson 28337 Maitland Lane Saugus, California 91350
JUL 1 5 2009
Re: K091156
Trade/Device Name: Trimed Sterile Product
Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: II
Product Code: HRS, JDS, HWC, NDL, HTY, MBI Dated: June 17, 2009 Received: June 19, 2009
Dear Ms. Anderson:
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.
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 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.
3
Page 2- Ms. Kelli Anderson
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Barbara Brienup
Mark N. Melkei Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K091156
Device Name:___Small Fragment Plates and Screws
Used as an aid to the healing of volar rim fractures of the distal radius.
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Souther for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091156
Page 1 of
5
510(k) Number (if known): K091156
Device Name:__________________________________________________________________________________________________________________________________________________________________
Used as an aid to the treatment of certain types of fractures involving small fragments. Specifically:
-
Cortical fragments large and strong enough to allow application of the device with fixation to an adjacent stable cortex of cortical bone.
-
An intraarticular fragment large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.
-
A combination of the above
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Saktu
dm mxu
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K091156
Page 1 of 1
6
510(k) Number (if known): __ K091156
Device Name: _ Tension Band Wire
Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, medial malleolus, lateral malleolus, distal ulna, distal humerus, and proximal humerus.
The decision to use a specific implant as well as the size and shape of the implant used must be based on sound medical judgement that takes into consideration factors such as the circumstances and configuration of the injury.
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Sousta
(Division Sign Off) Jo MKM
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091156
Page 1 of 1
7
510(k) Number (if known): K091156
Device Name: TriMed Bearing Plate: TriMed Volar Bearing Plate
-
Fixation of fractures or non-unions of the distal radius
-
Osteotomies of the distal radius to correct malunion.
Prescription Use (Part 21 CFR 801 Subpart D) 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)
Sauta for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091156
Page 1 of
8
510(k) Number (if known): K091156
Device Name:__________________________________________________________________________________________________________________________________________________________________
The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Page 1 of
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ooutu
(Division Sign-Off) for mxn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091156
9
510(k) Number (if known): K091156
Device Name:_ TriMed Bone Plates
The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Ometu
(Division Sign-Off) of mkm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091156
Page 1 of
10
510(k) Number (if known): K091156
Device Name: TriMed Tenodesis Cross Screw and Interference Screw
Indications For Use:
The TriMed Tenodesis Cross Screw and Interference Screw are intended to be used as an aid for fixation of soft tissue grafts to bone. Specific indications for use include:
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, Tendon Transfer in the hand and wrist.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruciton, Tendon Transfers in the foot and ankle.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Sputu for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091156
11
510(k) Number (if known): K091156
Device Name: TriMed Suture Bead
Indications For Use:
The TriMed Suture Bead is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting. The Suture Beads are also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment.
The TriMed Suture Bead is not indicated for use within intra-articular sites.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Onetia for MXM
vision Sig Division of Surgical, Orthopedic and Restorative Devices
510(k) Number