(143 days)
No
The summary describes a mechanical suture fixation system made of PEEK, with no mention of software, algorithms, or any AI/ML related terms or concepts. The performance studies are mechanical tests (pullout force, suture retention), not related to data analysis or image processing.
No
The device is a surgical implant designed to secure soft tissue to bone, not to treat a disease or medical condition itself.
No
Explanation: The Knotless Suture Fixation System is described as an implant used to secure soft tissue to bone for surgical treatment, not for diagnosing conditions.
No
The device description explicitly states that the system includes "threaded anchors" constructed of PEEK, which are physical implants used in surgery. This indicates the device is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used to secure soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implant (threaded anchors made of PEEK) used in surgery. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties like pullout force and suture retention, which are relevant to the structural integrity and function of a surgical implant. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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 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
Product codes
MBI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Hand and Wrist, Ankle/Foot
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 Test Summary: The following tests were performed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to other predicate devices. Pullout force Suture retention The results of these studies showed that the Knotless Suture Fixation System met the acceptance criteria.
Clinical Test Summary: No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Securus Suture Anchors (K090128), Opus® SpeedScrew™ (K100457)
Reference Device(s)
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
§ 888.3040 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.
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 Miller
Vice President
Phone: (215) 310-9534
Email: jeff.miller@ceortho.com |
| Trade Name | Core Essence Orthopaedics, Inc., TAC-tite™ PEEK |
|---|---|
| Common Name | Knotless Suture Fixation System |
| Device Class | Class II |
| Classification Name | |
| and Number | Fastener, Fixation, Non-degradable, Soft Tissue |
| 21 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 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. |
ﺘﺴ
| Intended 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 |
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 grade
Polyetheretherketone (PEEK)
Specifically PEEK-OPTIMA® manufactured by Invibio |
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Statement of
Technological
Comparison | The purpose of this submission is to obtain market clearance for the
proposed Core Essence Orthopaedics, Inc., Knotless Suture Fixation
System. Core Essence Orthopaedics, Inc., Knotless Suture Fixation
System and its predicate devices have the same indications for use, similar
design, and test results. The device and predicates are manufactured using
materials with a long history of use in orthopaedic implants. One of the
predicate anchors is made of Ti 6Al-4V ELI (Per ASTM F136 and ISO
5832-2). The new device and the other predicate are made of implant
grade 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 Test
Summary | The following tests were performed to demonstrate that the Knotless Suture Fixation
System is substantially equivalent to other predicate devices.
Pullout force Suture retention The results of these studies showed that the Knotless Suture Fixation System met the
acceptance criteria. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test
Summary | No clinical tests were performed. |
| Sterilization Information | |
|---|---|
| Implants | The Knotless Suture Fixation System will be sterilized using EtO. Sterilization |
| validation testing of the process was conducted on equivalent devices to achieve a | |
| Sterility Assurance Level (SAL) of 10-6, using the Half-cycle approach, per | |
| AAMI/ANSI/ISO/11135. | |
| Instruments and | |
| Case | The Knotless Suture Fixation System instrument and case will be shipped non-sterile and |
| will be autoclaveable, validation testing of the process was conducted on equivalent | |
| product 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 its
predicate devices have the same indications for use, have a similar design, and similar
test 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 Type
Cancellous 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