(143 days)
The Knotless Suture Fixation System is intended to secure soft tissue to bone of: The Shoulder, Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Rotator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radia! Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Ankle/Foot Indications: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
Knotless Suture Fixation System includes threaded anchors used to facilitate fixation of soft tissue to bone. This is a knotless suture anchor for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The implant is constructed of Polyetheretherketone (PEEK) which is widely used for products in the product code.
The provided text describes a 510(k) summary for the "Knotless Suture Fixation System" by Core Essence Orthopaedics, Inc. This document focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical or analytical setting with defined endpoints like accuracy, sensitivity, or specificity.
Here's a breakdown of the information based on your request, highlighting what is present and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pullout force | Met acceptance criteria |
| Suture retention | Met acceptance criteria |
| (Specific numerical criteria or thresholds are NOT provided in the document) | (Specific numerical results are NOT provided in the document) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "The following tests were performed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to other predicate devices: Pullout force Suture retention".
- Sample Size for Test Set: Not specified. The document only states that tests were performed to demonstrate equivalence.
- Data Provenance: Not specified. It's implicitly laboratory testing, but details like country of origin or whether the data is retrospective/prospective are not relevant for these types of mechanical tests and are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are mechanical (pullout force and suture retention), not diagnostic or clinical tests requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. Mechanical tests do not typically involve adjudication methods for ground truth, as the measurements are objective.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This device is a physical medical device (suture fixation system), not an algorithm or AI system.
7. Type of Ground Truth Used
The ground truth for the "pullout force" and "suture retention" mechanical tests would be the measured physical properties themselves, determined by standardized testing protocols (e.g., ASTM standards). The document indicates that the tests showed the device "met the acceptance criteria," implying there were objectively measurable thresholds.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of the Study and Acceptance Criteria:
The "study" described is a set of nonclinical mechanical tests (pullout force and suture retention) designed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to existing predicate devices. The acceptance criteria for these tests were met, confirming the device's mechanical integrity for its intended use. However, the document does not provide the specific numerical values for these acceptance criteria nor the detailed results or sample sizes from these tests. It only states that the criteria were met. No clinical studies were conducted or presented as part of this 510(k) submission.
{0}------------------------------------------------
Core Essence
Orthopaedics, Inc.
510(k) Summary
11 1716 # 15
NOV 1 0 2011
as required by section 807.92(c).
Knotless Suture Fixation System K11716
Core Essence Orthopaedics, Inc. 575A Virginia Dr.
Ft. Washington, PA 19034
Jeff Miller
Vice President
Phone: (215) 310-9534
Fax: (215) 660-5014
Email: jeff.miller(@ceortho.com
Updated 11/10/11
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains a sequence of characters and numbers. The sequence starts with "KII 1716" followed by a superscripted "2/5". The characters and numbers are handwritten and appear to be part of a label or identifier. The image is in black and white.
| Submitter: | Core Essence Orthopaedics, Inc.575A Virginia Dr.Ft. Washington, PA 19034 |
|---|---|
| Contact Person | Jeff MillerVice PresidentPhone: (215) 310-9534Email: jeff.miller@ceortho.com |
| Trade Name | Core Essence Orthopaedics, Inc., TAC-tite™ PEEK |
|---|---|
| Common Name | Knotless Suture Fixation System |
| Device Class | Class II |
| Classification Nameand Number | Fastener, Fixation, Non-degradable, Soft Tissue21 CFR 888.3040 |
| Classification Panel: | Orthopedic |
| Product Code | MBI |
| Predicate Devices | Securus Suture Anchors (K090128)Opus® SpeedScrew™ (K100457) |
| Device Description | Knotless Suture Fixation System includes threaded anchors used tofacilitate fixation of soft tissue to bone. This is a knotless sutureanchor for surgical treatment of ligament, tendon and soft tissuepathologies of the shoulder and other joints.The implant is constructed of Polyetheretherketone (PEEK) which iswidely used for products in the product code. |
ﺘﺴ
| Intended Use | The Knotless Suture Fixation System is intended to secure soft tissueto bone of: |
|---|---|
| The Shoulder: | |
| Bankart Repair | |
| SLAP Lesion Repair | |
| Acromio-Clavicular Separation | |
| Rotator Cuff Repair | |
| Capsule Repair | |
| Biceps Tenodesis | |
| Deltoid Repair |
{2}------------------------------------------------
KII 1716 *15
| The Elbow: | Ulnar or Radial Collateral Ligament Reconstruction |
|---|---|
| Bicep Tendon Reconstruction | |
| Tennis Elbow Repair | |
| The Hand and Wrist: | Scapholunate Ligament Reconstruction |
| Ulnar / Radial Collateral Ligament Reconstruction | |
| Ankle/Foot Indications: | Lateral Stabilization |
| Medial Stabilization | |
| Achilles Tendon Repair / Reconstruction | |
| Hallux Valgus Reconstruction | |
| Mid and Rear Foot Reconstruction |
| Materials: | The implant is manufactured from ASTM2026 implant gradePolyetheretherketone (PEEK)Specifically PEEK-OPTIMA® manufactured by Invibio |
|---|---|
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------- |
| Statement ofTechnologicalComparison | The purpose of this submission is to obtain market clearance for theproposed Core Essence Orthopaedics, Inc., Knotless Suture FixationSystem. Core Essence Orthopaedics, Inc., Knotless Suture FixationSystem and its predicate devices have the same indications for use, similardesign, and test results. The device and predicates are manufactured usingmaterials with a long history of use in orthopaedic implants. One of thepredicate anchors is made of Ti 6Al-4V ELI (Per ASTM F136 and ISO5832-2). The new device and the other predicate are made of implantgrade Polyetheretherketone (PEEK) (Per ASTM2026). |
|---|---|
| --------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Summary of Technological Comparison (Please see below)
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains a handwritten string of characters and numbers. The string appears to be "K111716#4/5". The characters are written in black ink on a white background. The handwriting is somewhat messy and uneven.
| Nonclinical TestSummary | The following tests were performed to demonstrate that the Knotless Suture FixationSystem is substantially equivalent to other predicate devices.Pullout force Suture retention The results of these studies showed that the Knotless Suture Fixation System met theacceptance criteria. |
|---|---|
| Clinical TestSummary | No clinical tests were performed. |
| Sterilization Information | |
|---|---|
| Implants | The Knotless Suture Fixation System will be sterilized using EtO. Sterilizationvalidation testing of the process was conducted on equivalent devices to achieve aSterility Assurance Level (SAL) of 10-6, using the Half-cycle approach, perAAMI/ANSI/ISO/11135. |
| Instruments andCase | The Knotless Suture Fixation System instrument and case will be shipped non-sterile andwill be autoclaveable, validation testing of the process was conducted on equivalentproduct to an Sterility Assurance Level (SAL) of 10-6 per ISO 11134. |
| Conclusion | The Knotless Suture Fixation System is substantially equivalent to its predicate devices.This conclusion is based upon the fact the Knotless Suture Fixation System and itspredicate devices have the same indications for use, have a similar design, and similartest results. |
|---|
{4}------------------------------------------------
| Characteristic | Knotless Suture Fixation System | TAC-tite™ Suture Anchor(Previously cleared Securus)(K090128) | Opus® SpeedScrew™(K100457) |
|---|---|---|---|
| Intended Use | Same | Same | Both indicated for knotless fixation device for fixation of soft tissue to bone, and examples of procedures are similar. |
| Material | PEEK-OPTIMA® | Ti6Al4V | PEEK-OPTIMA® |
| Anchor Type | Screw Type | Screw TypeCancellous Style Buttress Thread | Screw Type |
| Suture Lock | Knotless | Knotless | Knotless |
| Performance Specs. | Same | Same | Similar |
K 11/17/14 21 5
{5}------------------------------------------------
NOV 1 0 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Core Essence Orthopaedics % Mr. Jeff Miller Vice President 575A Virginia Drive Fort Washington, Pennsylvania 19034
Re: K111716
Trade/Device Name: Core Essence Orthopaedics, Inc., Knotless Suture Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 2, 2011 Received: November 3. 2011
Dear Mr. Miller:
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 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
{6}------------------------------------------------
Page 2 - Mr. Jeff Miller
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.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,
for Peter Dazlers D.O.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
Indications for Use
11716
510(k) Number K111716
Device Name: Core Essence Orthopaedics, Inc., Knotless Suture Fixation System
Indications for Use:
The Knotless Suture Fixation System is intended to secure soft tissue to bone of: The Shoulder,
Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Rotator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radia! Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Ankle/Foot Indications: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction
Mid and Rear Foot Reconstruction
Prescription Use X AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111716
§ 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.