(29 days)
No
The device description and performance studies focus on the mechanical properties of the suture and anchor, with no mention of AI or ML technology.
Yes.
The device is indicated for securing soft tissue to bone or soft tissue reattachment in the hand, which falls under the definition of therapeutic intervention to treat an injury or condition.
No
The device is a nonabsorbable suture and suture anchor system used to secure soft tissue to bone/soft tissue reattachment in the hand, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components including a 316L stainless steel anchor, UHMWPe sutures, cutting needles, a single-use driver, and a hand piece. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the PONTiSTM device is a suture and suture anchor system intended for securing soft tissue to soft tissue or bone reattachment in the hand. This is a surgical implant used directly on the patient's body during a procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device is a physical implant used for mechanical support.
Therefore, based on the provided information, the PONTiSTM device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PONTISTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to soft tissue reattachment in the hand:
Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
The PONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to bone reattachment in the hand:
Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
Product codes (comma separated list FDA assigned to the subject device)
The full entry from the provided document is:
PONTISTM Ultra-High Molecular Weight Polyethylene Suture
• GAT (suture, nonabsorbable, synthetic, polyethylene)
PONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-
High Molecular Weight Polyethylene Braided Suture
• MBI (fastener, fixation, nondegradable, soft tissue)
• GAT (suture, nonabsorbable, synthetic, polyethylene)
This implies the product codes are GAT and MBI. However, the exact output format must follow the instructions "comma separated list FDA assigned to the subject device". From the FDA letter, the product codes provided are: MBI, GAT.
Device Description
Brief Description of the Device, Sutures
The PONTISTM 3mm anchor is made of 316L stainless steel and incorporates non-absorbable UHMWPe sutures which are available in United States Pharmacopoeia (USP) sizes 4-0 to 2-0 in various lengths and cleared to market under K094028. UHMWPe sutures and 316L Stainless steel are used in a wide variety of medical devices including previously approved implants of this type. The UHMWPe Sutures will be secured by knot tying. The UHMWPe sutures are supplied sterile and armed with cutting needles. A single use driver and hand piece will hold the excess suture, which delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone. The anchor is the same as was cleared under K101126, PONTIS Sutures and Suture Anchor with Optional Crimps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, PIP, DIP, MCP Joints.
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)
Nonclinical Tests Performed
A collection of tests was conducted to determine safety and performance on the proposed device. Additionally, the subject device labeling is consistent both with FDA's guidance as well as current medical practice. The PONTiSTM 3mm Suture Anchors with UHMWPe was compared in standardized foam bone model materials. The Anchor insertion torque, suture strength (knot pull), pull-out failure mechanism (pull-out or suture break strength) and pullout failure force were documented. In all performance tests the PONTiSTM UHMWPe Sutures and 3mm Suture Anchors with UHMWPe Suture secured by knots are equivalent to products currently marketed for the same indications as confirmed by a comparison to the literature documenting the comparative characteristics of suture anchors.
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.
PONTISTM Sutures and Suture Anchors with Optional Crimps K101126
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.
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
§ 888.3040 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.
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Image /page/0/Picture/2 description: The image shows the logo for Pontis Orthopaedics. The word "PONTIS" is written in large, bold letters, with the word "ORTHOPAEDICS" written in smaller letters below it. There is a curved line above the "S" in "PONTIS".
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1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -
| Owner's Name | Leonard Gordon |
|---|---|
| Submitter Address | 2299 Post Street Suite 107 |
| San Francisco, CA 94115 | |
| Phone Number | (415) 567-8935 |
| Fax Number | (415) 567-8934 |
| 510(k) Owner | PONTIS Orthopaedics, LLC |
| Contact Person | Leonard Gordon |
| President | |
| Date Prepared | June 24, 2014 |
| Trade Name | PONTISTM Ultra-High Molecular Weight Polyethylene Suture and |
| PONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-High | |
| Molecular Weight Polyethylene Braided Suture | |
| Common name | 1. Suture, nonabsorbable, synthetic, polyethylene |
- Suture, Anchor |
| Classification Name | Class II 21 CFR § 888.3040 Smooth or threaded metallic bone
fixation fastener
Class II 21 CFR § 878.5000 Nonabsorbable poly(ethylene
terephthalate) surgical suture |
| Section | §C.F.R. Section 878.4495 |
| Product Code | PONTISTM Ultra-High Molecular Weight Polyethylene Suture
• GAT (suture, nonabsorbable, synthetic, polyethylene)
PONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-
High Molecular Weight Polyethylene Braided Suture
• MBI (fastener, fixation, nondegradable, soft tissue)
• GAT (suture, nonabsorbable, synthetic, polyethylene) |
| Predicate Device | PONTISTM Sutures and Suture Anchors with Optional Crimps
K101126 |
| Device Description | Brief Description of the Device, Sutures
The PONTISTM 3mm anchor is made of 316L stainless steel and
incorporates non-absorbable UHMWPe sutures which are |
| | available in United States Pharmacopoeia (USP) sizes 4-0 to 2-0 in various lengths and cleared to market under K094028. UHMWPe sutures and 316L Stainless steel are used in a wide variety of medical devices including previously approved implants of this type. The UHMWPe Sutures will be secured by knot tying. The UHMWPe sutures are supplied sterile and armed with cutting needles. A single use driver and hand piece will hold the excess suture, which delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone. The anchor is the same as was cleared under K101126, PONTIS Sutures and Suture Anchor with Optional Crimps. |
| Reason for 510(k) | Modified Device (suture change only) |
| Indications for Use | The PONTIS™ Nonabsorbable Ultra-High Molecular Weight
Polyethylene Braided Suture are indicated to secure soft tissue to
soft tissue reattachment in the hand:
Collateral Ligaments around the PIP, DIP and MCP
Joints Flexor and Extensor Tendons The PONTIS™ 3mm Nonabsorbable Suture Anchors with Ultra-
High Molecular Weight Polyethylene Braided Suture are indicated
to secure soft tissue to bone reattachment in the hand:
Collateral Ligaments around the PIP, DIP and MCP
Joints Flexor and Extensor Tendons |
| Technological
Characteristics | The PONTIS 3mm Suture Anchor is the same anchor cleared
under K101126. All biocompatibility testing performed, which
was conducted under the predicate submissions K101126 remain
applicable for this submission as is contains the same materials.
The suture material has changed to Ultra High Molecular Weight
Polyethylene Suture. UHMWPe sutures, which was cleared under
K094028. This indicates that the components are safe for their
intended use.
The PONTIS 3mm Anchor with UHMWPe as well as the
predicate is a single use, implantable device, sterilized by ethylene
oxide. |
510(K) Summary
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Substantial Equivalence The substantial equivalence of the PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Suture and PONTISTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture is based on the equivalence in intended use, operational principals, and indications for use to the predicate PONTISTM Sutures and Suture Anchors with Optional Crimp (K101126). The only difference is the suture type, which is being changed to Ultra High Molecular Weight Polyethylene Suture (UHMWPe) instead of stainless steel. The sutures will be secured by knots instead of an alternate crimp. The UHMWPe sutures were cleared to market under K094028. PONTiSTM UHMWPe Sutures and PONTiSTM 3mm Suture Anchors with UHMWPe suture are substantially equivalent to other sutures currently marketed in conjunction with suture anchors and present no substantial differences in design, intended use and function to previously approved products. Nonclinical Tests A collection of tests was conducted to determine safety and Performed performance on the proposed device. Additionally, the subject device labeling is consistent both with FDA's guidance as well as current medical practice. The PONTiSTM 3mm Suture Anchors with UHMWPe was compared in standardized foam bone model materials. The Anchor insertion torque, suture strength (knot pull), pull-out failure mechanism (pull-out or suture break strength) and pullout failure force were documented. In addition cyclic pull-out performance was characterized. In all performance tests the PONTiSTM UHMWPe Sutures and 3mm Suture Anchors with UHMWPe Suture secured by knots are equivalent to products currently marketed for the same indications as confirmed by a comparison to the literature documenting the comparative characteristics of suture anchors. The performance studies and biocompatibility reviews indicate that the PONTiSTM UHMWPe sutures are safe for their intended use. Conclusions Drawn The testing demonstrated that the products are equivalent and did not affect safety and efficacy of the device or raise any new questions of safety or efficacy.
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| | Based on the indications for use, technological characteristics and
performance test results, the PONTiS™ UHMWPe Sutures and
3mm Suture Anchors with UHMWPe suture is substantially
equivalent to the predicate PONTiS™ Sutures and Suture Anchors
with Optional Crimp K101126 and present no substantial
differences in design, intended use and function. |
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END OF 510(k) SUMMARY
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20903-0002
July 24, 2014
PONTIS Orthopaedics, LLC Dr. Leonard Gordon President 2299 Post Street, Suite 103 San Francisco, California 94115
Re: K141711
Trade/Device Name: PONTiS Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures and PONTiS'100 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, GAT Dated: June 24, 2014 Received: June 25, 2014
Dear Dr. Gordon:
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
5
Page 2 - Dr. Leonard Gordon
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): K141711
Manufacturer: PONTiS Orthopaedics, LLC
Device Name: PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures and PONTIS™ 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture
Indications for Use:
The PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures are indicated to secure soft tissue to soft tissue reattachment in the hand:
- Collateral Ligaments around the PIP, DIP and MCP Joints .
- . Flexor and Extensor Tendons
The PONTiSTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to bone reattachment in the hand:
- Collateral Ligaments around the PIP, DIP and MCP Joints .
- Flexor and Extensor Tendons ●
| Prescription Use
(21 CFR Part 801 Subpart D) | XX | AND/OR | Over the Counter Use
(21 CFR Part 801 Subpart C) |
| ------------------------------------------------- | ---- | -------- | ----------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Elizabeth 詞&aank -S
Division of Orthopedic Devices