(268 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of a surgical anchor and suture, with no mention of AI or ML.
No
The device is an implant used for soft tissue fixation to bone during surgical procedures, which assists in healing but does not directly deliver therapy or perform a therapeutic function on its own.
No
The device is a surgical implant (suture anchors) used for soft tissue fixation, not for diagnosing medical conditions. Its intended use is for repair and reconstruction in various anatomical sites during surgical procedures.
No
The device description clearly states it is a physical implant (Screw Anchor & Wedge Anchor) made of PEEK and UHMWPE suture, supplied sterile and ready to use with a disposable inserter assembly. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in surgical procedures for soft tissue fixation to bone in various anatomical locations. This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as an implant (screw anchor and wedge anchor) preloaded with suture, tape, or suture-tape combinations, supplied sterile and ready to use for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implant used inside the body during surgery.
N/A
Intended Use / Indications for Use
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:
-
- Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
-
- Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy.
-
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
-
- Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
-
- Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hand, wrist, elbow, shoulder, hip
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)
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor and Predicate device underwent tests to determine their pull-out strength, cyclical loading and drive in torque test. Results demonstrated that the CEPTRE® Knotted UHMWPE Suture PEEK Anchor performs statistically equivalent to the predicate device.
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.
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.
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
January 4, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Healthium Medtech Limited Pankaj Dawar Deputy General Manager Regulatory Affair 472-D, 13th Cross, 4th Phase, Peenya Industrial Area Bangalore, Karnataka 560058 India
Re: K231033
Trade/Device Name: CEPTRE® Knotted UHMWPE Suture PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 2, 2023 Received: December 4, 2023
Dear Pankaj Dawar:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Digitally signed by Jesse
Jesse Muir -S Muir-S
Date: 2024.01.04 10:17:30
-05'00'
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231033
Device Name
CEPTRE® Knotted UHMWPE Suture PEEK Anchor
Indications for Use (Describe)
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:
-
- Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
-
- Foot Ankle: Lateral Stabilization, Medial stabilization, Achilles Tendon repair, Hallux Valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy.
-
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
-
- Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
-
- Hip: Acetabular labral repair, Capsular repair and gluteus medius repair.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------- |
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4
Image /page/4/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/4/Picture/1 description: The image contains the text 'K231033' at the top. Below that is a logo for 'Healthium'. The logo consists of the word 'Healthium' in a bold, sans-serif font, with a stylized graphic to the right. The graphic appears to be two overlapping circles, one blue and one orange, with a white cross shape imposed over them.
1. 510(k) Summary
1.1. Submitter Information:
| Application Correspondent: | PANKAJ DAWAR |
|---|---|
| Healthium Medtech Limited | |
| 472-D, 13th Cross, 4th Phase, | |
| Peenya Industrial Area, | |
| Bangalore Karnataka 560058, India | |
| Phone: | +91-9886529934 |
| E-mail: | pankaj.d@healthiummedtech.com |
| Specification Developer: | Healthium Medtech Limited |
| 472-D, 13th Cross, 4th Phase, | |
| Peenya Industrial Area, | |
| Bangalore, Karnataka 560058, India | |
| Phone: | +91 - 80 - 41868000 |
| Contact Person: | PANKAJ DAWAR |
| E-mail: | pankaj.d@healthiummedtech.com |
| Date Prepared: | 03-01-2024 |
| 1.2. Device Identification: | |
| Device Trade Name: | CEPTRE® Knotted UHMWPE Suture PEEK Anchor. |
| Device Common Name: | Non-Absorbable Suture Anchor |
| Classification Name: | Smooth or threaded metallic bone fixation fastener. |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 888.3040 |
MBI Product Code:
5
Image /page/5/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/5/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one orange and one blue, with a white plus sign in the center.
1.3. Predicate Devices:
Table 1 - List of Predicate Devices
| Device Name | 510(k) Number | S.No | Parameters | Arthrex
Suture
(K143745) | Corkscrew
Anchors | Arthrex
Suture Anchors
(K140855) | CEPTRE®
Knotted
UHMWPE
Suture PEEK
Anchor
(Subject Device) |
|----------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Arthrex Corkscrew Suture Anchors | K143745 | 1. | Manufacturer | Arthrex, Incorporated | Arthrex, Incorporated | Arthrex, Incorporated | Healthium
Medtech Limited |
| Arthrex SutureTak Suture Anchors | K140855 | 2. | Product Code | MBI | | MAI (Classification
Product Code)
MBI (Subsequent Product
Code) | MBI |
| 3. | Regulation
Number | 21 CFR 888.3040 | | 21 CFR 888.3030 | 21 CFR 888.3040 | | |
| 4. | Classification | Class II | | Class II | Class II | | |
| 5. | Intended Use | The Arthrex Corkscrew
suture anchors are
intended to be used for
fixation of suture (soft
tissue) to bone in the
shoulder, foot/ankle,
hip, knee, hand/wrist,
and elbow in the
following procedures:
• Shoulder: Rotator
Cuff Repair, Bankart
Repair, SLAP
Lesion Repair,
Biceps Tenodesis,
Acromio-Clavicular
Separation Repair,
Deltoid Repair,
Capsular Shift or
Capsulolabral
Reconstruction.
• Foot/Ankle:
Lateral
Stabilization,
Medial
Stabilization,
Achilles
Tendon Repair,
Hallux Valgus
Reconstruction,
Mid-foot
Reconstruction,
Metatarsal
Ligament
Repair/Tendon
Repair and
Bunionectomy. | | The Arthrex SutureTak
suture anchors are
intended to be used for
suture (soft tissue)
fixation to bone in the
foot, ankle, knee, hand,
wrist, elbow, shoulder,
and hip.
• Shoulder: Rotator Cuff
Repair, Bankart Repair,
SLAP Lesion Repair,
Biceps Tenodesis,
Acromio-Clabicular
Separation Repair,
Deltoid Repair,
Capsular Shift or
Capsulolabral
Reconstruction
• Foot/Ankle: Lateral
Stabilization, Medial
Stabilization, Achilles
Tendon Repair,
Metatarsal Ligament
Repair, Hallux Valgus
reconstruction, digital
tendon transfers, Mid-
foot reconstruction
• Knee: Medial Collateral
Ligament Repair,
Lateral Collateral
Ligament Repair,
Patellar Tendon Repair,
Posterior Oblique
Ligament Repair,
Iliotibial Band
Tenodesis | The CEPTRE®
Knotted
UHMWPE Suture
PEEK Anchor are
indicated in
surgical
procedures for soft
tissue fixation to
bone in the foot,
ankle, knee, hand,
wrist, elbow,
shoulder and hip
for the following
indications:
- Shoulder:
Rotator Cuff
Repair,
Bankart
Repair, SLAP
Lesion Repair,
Biceps
Tenodesis,
Acromio-
Clavicular
Separation
Repair,
Deltoid Repair
Capsular Shift
or
Capsulolabral
Reconstruction
• 2. Foot/Ankle:
Lateral
Stabilization,
Medial
stabilization | | |
Device Description 1.4.
The CEPTRE® Knotted UHMWPE Suture PEEK Anchors are available as Screw Anchor (threaded) & Wedge Anchor (Tap in) which are preloaded with suture(s), tape(s) or suture-tape combinations on a disposable inserter assembly. The implant is supplied sterile and ready to use.
1.5. Indications for Use
Indications for Use
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor are indicated in surgical procedures for soft tissue fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder and hip for the following indications:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, 1. Acromio-Clavicular Separation Repair, Deltoid Repair Capsular Shift or Capsulolabral Reconstruction.
- Foot/Ankle: Lateral Stabilization. Medial stabilization. Achilles Tendon repair. Hallux Valgus 2. reconstruction, Mid-foot reconstruction, Metatarsal ligament repair, Digital tendon transfers and Bunionectomy
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral ligament repair, Lateral collateral 3. ligament repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Iliotibial band tenodesis.
-
- Hand/Wrist: Scapholunate ligament reconstruction. Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital tendon transfers.
- న్. Elbow: Biceps tendon reattachment, Tennis Elbow Repair, Ulnar or Radial collateral ligament reconstruction, and lateral Epicondylitis repair.
- Hip: Acetabular labral repair, Capsular repair and gluteus medius repair. 6.
1.6. Comparison of Technological Characteristics
The fundamental scientific technology, materials of construction and mechanism of operation are similar between the subject device CEPTRE® Knotted UHMWPE Suture PEEK Anchor and the predicate devices. Table 2 summarizes the comparison of technological characteristics between the subject and predicate device.
Table 2 - Substantial Equivalence Table
6
Image /page/6/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" replaced by a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, lighter font.
Image /page/6/Picture/1 description: The image contains the word "Healthium" in a blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles. The bottom circle is blue, and the top circle is orange.
7
Image /page/7/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is in a bold, sans-serif font, with the "O" in "Sironix" being a red circle. Below "Sironix" is the text "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/7/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one blue and one orange. The blue circle is in the foreground and the orange circle is in the background.
| S.No | Parameters | Arthrex
Suture
(K143745) | Corkscrew
Anchors | Arthrex
Suture Anchors
(K140855) | SutureTak
CEPTRE®
Knotted
UHMWPE
Suture PEEK
Anchor
(Subject Device) | |
|------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Knee: Anterior
Cruciate Ligament
Repair, Medial
Collateral
Ligament Repair,
Lateral Collateral
Ligament Repair,
Patellar Tendon
Repair, Posterior
Oblique Ligament
Repair, and
Illiotibial Band
Tenodesis. Hand/Wrist:
Scapholunate
Ligament
Reconstruction,
Ulnar or Radial
Collateral
Ligament
Reconstruction. Elbow: Biceps
Tendon
Reattachment,
Tennis Elbow
Repair, Ulnar
or Radial
Collateral
Ligament
Reconstruction,
Lateral
Epicondylitis
repair. Hip: Capsular
repair,
acetabular
labral repair,
gluteus medius
repair. | | Hand/Wrist:
Scapholunate
Ligament
Reconstruction,
Carpal Ligament
Reconstruction,
Repair/Reconstruction
of collateral
ligaments, Repair of
Flexor and Extensor
Tendons at the PIP,
DIP, and MCP joints
for all digits, digital
tendon transfers Elbow: Biceps
Tendon Reattachment,
Ulnar or Radial
Collateral Ligament
Reconstruction Hip: Capsular repair,
Acetabular Labral
repair | Achilles
Tendon repair,
Hallux Valgus
reconstruction,
Mid-foot
reconstruction,
Metatarsal
ligament
repair/tendon
repair, Digital
tendon
transfers and
Bunionectomy
3. Knee: Anterior
Cruciate
Ligament
Repair, Medial
Collateral
ligament
repair, Lateral
collateral
ligament
repair, Patellar
Tendon
Repair,
Posterior
Oblique
Ligament
Repair and
Iliotibial band
tenodesis.
4. Hand/Wrist:
Scapholunate
ligament
reconstruction,
Ulnar or
Radial
Collateral
Ligament
Reconstruction
, Carpal
Ligament
Reconstruction
,
Repair/Recons
truction of
collateral
ligaments, | |
| S.No | Parameters | Arthrex
Suture
(K143745) | Corkscrew
Anchors | Arthrex
Suture Anchors
(K140855) | CEPTRE®
Knotted
UHMWPE
Suture PEEK
Anchor
(Subject Device) | |
| 6. | Anchor
Material | PEEK | PEEK | PEEK | PEEK | |
| 7. | Suture / Tape
Material | UHWMPE
or
a
polyblend
of
UHMWPE
and
polyester | | UHWMPE or a polyblend
of UHWMPE and
polyester | Suture-UHMWPE
USP#2
Tape- UHMWPE
1.5mm Round-
Flat-Round | |
| 8. | Design
Feature | The Arthrex Corkscrew
is fully threaded suture
anchors
designed for maximum
fixation strength and
simple
insertion. An internal
drive mechanism is
combined with
a unique eyelet to allow
for continuous | | The SutureTak Suture
Anchors are threaded
made up of PEEK
material, designed for
maximum fixation
strength.
The implant is provided
preloaded on an inserter
and may include eyelets
which are preloaded with
various types of suture, | Repair of
Flexor and
Extensor
Tendons at the
PIP, DIP, and
MCP joints for
all digits,
Digital tendon
transfers.
5. Elbow: Biceps
tendon
reattachment,
Tennis Elbow
Repair, Ulnar
or Radial
collateral
ligament
reconstruction,
and lateral
Epicondylitis
repair.
6. Hip:
Acetabular
labral repair,
Capsular repair
and gluteus
medius repair. | |
| | | | | | with the suture(s),
tape(s) or suture-
tape combinations | |
| S.No | Parameters | Arthrex
Suture
(K143745) | Corkscrew
Anchors | Arthrex Suture Anchors
(K140855) | SutureTak | CEPTRE®
Knotted
UHMWPE
Suture PEEK
Anchor
(Subject Device) |
| | | threads along the entire
length of the anchor.
The anchors
are loaded with
FiberWire sutures or
tapes to provide
superior repair strength. | | | | made up of
UHMWPE on the
disposable Sterile
Inserters. |
| 9. | Specifications
and
Dimensions | PEEK
Corkscrew FT
Suture Anchor,
4.5 mm x 14
mm w/two #2
FiberWire (1
Blue, 1
White/Black) PEEK
Corkscrew FT
Suture Anchor,
4.75 mm x 14
mm w/two 1.3
mm
SutureTapes
(White/Black,
White/Blue) PEEK
Corkscrew FT
Suture Anchor,
4.75 mm x 14
mm w/two 1.3
mm
SutureTapes
(White/Black,
White/Blue) PEEK
Corkscrew FT
Suture Anchor,
5.5 mm x 14.7
mm w/three #2
FiberWire | | SutureTak Suture
Anchor 2mm x
12mm #1
FiberWire SutureTak Suture
Anchor 2.4 mm x
12mm #2
FiberWire SutureTak Suture
Anchor 3 mm x
14mm #2
Fiber Wire SutureTak Suture
Anchor 3 mm x
14mm #2
FiberWire, qty. 2 | | Wedge anchor:
USP #2 Suture
Loaded-
2.5mm, Length
12mm USP #2 Double
Sutures
Loaded-
2.8mm, Length
12mm 1.5mm Double
Tapes Loaded-
2.8mm, Length
12mm Screw anchor:
USP #2 Suture
& 1.5mm Tape
Loaded-
4.8mm, Length
15mm USP #2 Double
Sutures
Loaded-
4.8mm, Length
15mm 1.5mm Double
Tapes Loaded-
4.8mm, Length
15mm USP #2 Suture
&1.5mm Tape
Loaded-
5.5mm, Length
15mm USP #2 Double
Sutures
Loaded-
5.5mm, Length
15mm |
| S.No | Parameters | Arthrex
Suture
(K143745) | Corkscrew
Anchors | Arthrex
Suture Anchors
(K140855) | CEPTRE®
Knotted
UHMWPE
Suture PEEK
Anchor
(Subject Device) | |
| | | | PEEK
Corkscrew FT
Suture Anchor,
6.5 mm x 14.7
mm w/two #2
FiberWire | | 1.5mm Double
Tapes Loaded-
5.5mm, Length
15mm USP #2 Triple
Sutures
Loaded-
5.5mm, Length
15mm | |
| 10 | Single
Use/Reuse | Single Use | | Single Use | Single Use | |
| 11 | Shelf Life | 5 Years | | 5 Years | 5 Years | |
| 12 | Sterilization
Method | EtO | | EtO | EtO | |
| 13 | Performance
Data | Insertion testing, Static
pull-out Testing,
Fatigue testing | | Tensile testing
Fatigue testing | Drive In Torque
Pull-Out Test
Cyclical Loading | |
| 14 | Safety Data | No Data Available | | No Data Available | Skin
Sensitization Intracutaneous
reactivity Material
Mediated
Pyrogenicity Acute Systemic
Toxicity In vitro
cytotoxicity Bone
Implantation Muscle
Implantation Bacterial
Endotoxin | |
8
Image /page/8/Picture/0 description: The image shows the logo for Sironix. The word "Sironix" is written in a sans-serif font, with the "O" in "Sironix" being a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller font.
Image /page/8/Picture/1 description: The image shows the logo for Healthium. The word "Healthium" is written in a blue, sans-serif font. To the right of the word is a graphic of two overlapping circles, one blue and one orange, with a white plus sign in the center.
9
Image /page/9/Picture/0 description: The image shows the logo for Sironix. The word "Sironix" is written in a sans-serif font, with the "O" in "Sironix" being a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller font.
Image /page/9/Picture/1 description: The image shows the logo for Healthium. The word "Healthium" is written in blue, with the "H" capitalized. To the right of the word is a graphic of two overlapping circles, one blue and one orange. The blue circle has a white plus sign in the middle.
10
Image /page/10/Picture/0 description: The image shows the logo for Sironix. The word "SIRONIX" is written in a sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "ArthroscopySolutions" in a smaller font.
Image /page/10/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one blue. A white plus sign is visible in the blue circle.
1.7. Summary of Performance Data
The CEPTRE® Knotted UHMWPE Suture PEEK Anchor and Predicate device underwent tests to determine their pull-out strength, cyclical loading and drive in torque test. Results demonstrated that the CEPTRE® Knotted UHMWPE Suture PEEK Anchor performs statistically equivalent to the predicate device.
11
Image /page/11/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.
Image /page/11/Picture/1 description: The image shows the logo for Healthium. The logo consists of the word "Healthium" in a dark blue, sans-serif font. To the right of the word is a graphic consisting of two overlapping circles, one orange and one dark blue. A white plus sign is superimposed over the circles.
1.8. Non-Clinical Testing
The Static pull out testing and cyclic loading were performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.
Bacterial endotoxin per USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling.
1.9. Conclusion
There are no significant differences between the subject device and the predicate devices that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate devices (Arthrex Corkscrew Suture Anchors and Arthrex SutureTak Suture Anchors) in design, Intended use, Indications for use, function, Sterilization method, Shelf Life, and operational principles. From the data available we can justify that the CEPTRE® Knotted UHMWPE Suture PEEK Anchor is as safe, and as effective and performs the same indications for use as that of already marketed predicate device identified.