(85 days)
The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
The ORTHOSORB 1.3mm and 2.0mm Resorbable Pins are made from poly-p-dioxanone and are available in 1.3mm and 2.0mm diameters and 40mm and 50mm lengths with their accompanying instrumentation.
This is not a medical imaging AI device. The provided text describes a 510(k) summary for a resorbable pin (ORTHOSORB Resorbable Pin) made from poly-p-dioxanone, intended for fixing small bony or chondral fragments.
Therefore, many of the requested categories (acceptance criteria for AI performance, sample size for test/training sets, expert qualifications, MRMC studies, etc.) are not applicable to this type of medical device submission.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance for ORTHOSORB Resorbable Pin (K111077)
| Acceptance Criteria Category | Reported Device Performance / Description |
|---|---|
| Substantial Equivalence | The ORTHOSORB Resorbable pins that are the subject of this submission are equivalent to the predicate device (ORTHOSORB Resorbable Pin, K901456). The technological characteristics are identical in terms of design, material, and performance. |
| Material Composition | Made from poly-p-dioxanone. Based on material, the pins are considered MR Safe as defined in ASTM F2503. |
| Device Dimensions | Available in 1.3mm and 2.0mm diameters and 40mm and 50mm lengths. |
| Intended Use/Indications | To fix in place small bony or chondral fragments in the knee and hand (e.g., osteochondritis dissecans, fractures of phalanges and metacarpals); for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for lesser toe deformities. Can provide additional support in finger joint fusion and digit replantation where standard fixation/support techniques are also employed. This aligns with the predicate device's indications. |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act for these devices. (This is a statement of non-applicability of specific FDA performance standards, not a device-specific performance metric.) |
| Regulatory Classification | Class II, Regulation Number 21 CFR 888.3040, Product Code OVZ (Smooth or threaded metallic bone fixation fastener). The device is regulated as substantially equivalent to a predicate product in this class. |
Non-Applicable Information for this Device (as it's not an AI/imaging device)
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI model. "Test set" refers to data for evaluating AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context refers to clinical labels for AI data. The "truth" for this device is its physical and material properties and its function.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This applies to expert labeling for AI device evaluation.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are used to evaluate diagnostic performance of imaging AI with human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI evaluation. For this device, the "ground truth" would relate to its manufacturing specifications, material properties, and mechanical performance tests, which are not detailed in this 510(k) summary (as it relies on equivalence to a predicate).
- The sample size for the training set: Not applicable. There is no training set for a physical resorbable pin.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):
The provided 510(k) summary indicates that the device (ORTHOSORB Resorbable Pin) meets its "acceptance criteria" primarily through a demonstration of substantial equivalence to a previously legally marketed predicate device (ORTHOSORB Resorbable Pin, K901456).
The "study" or justification for this is a direct comparison of the new device to the predicate device, asserting that:
- Technological Characteristics: They are identical in terms of design, material, and performance.
- Indications for Use: The indications for use are the same.
- Material Properties: Both are made from poly-p-dioxanone, and the MR safety (based on ASTM F2503) of the material is noted.
This type of submission typically relies on a comparison of specifications, engineering drawings, material data, and, if necessary, non-clinical bench testing (e.g., mechanical strength, degradation profiles) to demonstrate that the new device performs as safely and effectively as the predicate, and thus meets the "acceptance criteria" for market clearance via the 510(k) pathway. The specific details of these comparative tests are not provided in the summary document but form the basis of the substantial equivalence claim.
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510(k) Summary
| General Provisions | The name of the device is: | ||||
|---|---|---|---|---|---|
| Proprietary Name Common or Usual Name ORTHOSORB® Resorbable Pins Pin, Fixation, Resorbable, Hard Tissue | |||||
| Name of Predicate Devices | The device is substantially equivalent to the currently marketed ORTHOSORB Resorbable Pin, K901456. | ||||
| Classification | Class II, Regulation Number 21 CFR 888.3040, Product Code OVZ | ||||
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act for these devices. | ||||
| Device Description | The ORTHOSORB 1.3mm and 2.0mm Resorbable Pins are made from poly-p-dioxanone and are available in 1.3mm and 2.0mm diameters and 40mm and 50mm lengths with their accompanying instrumentation. | ||||
| Indications for Use | The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed. | ||||
| Technological Characteristics | The technological characteristics of the ORTHOSORB Resorbable pins that are the subject of this submission remain unchanged from the predicate device in terms of design, material and performance. |
JUL 12 2011 K111077
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Summary of Substantial Equivalence
The ORTHOSORB Resorbable pins that are the subject of this submission are equivalent to the predicate device. The technological characteristics are identical. Based on material, the pins are considered MR Safe as defined in ASTM F2503.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 1 2 2011
DePuy Orthopaedics, Inc. % Ms. Suzana Otaño 700 Orthopaedic Drive Warsaw, IN 46581-0988
Re: K111077
Trade/Device Name: ORTHOSORB Resorbable Pin Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: OVZ Dated: April 14, 2011 Received: April 18, 2011
Dear Ms. Otaño.
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. Iisting 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 mav 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
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Page 2 - Ms. Suzana Otaño
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.
E. Keith
A 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:
K111077
Device Name:
ORTHOSORB Resorbable Pin
Indications For Use:
The ORTHOSORB Resorbable pin are indicated for use to fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
Prescription Use A (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (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
for M. Meukerm
(Division Sigh-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111077
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.