PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
Device Facts
| Record ID | K252644 |
|---|---|
| Device Name | PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture |
| Applicant | M/s. Meril Endo Surgery Private Limited. |
| Product Code | NEW · General, Plastic Surgery |
| Decision Date | Sep 23, 2025 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4840 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
PINION™ PDO Knotless Suture is indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. PINION™ PGA-PCL Knotless Sutures are indicated for use in soft tissue approximation where use of an absorbable suture is appropriate.
Device Story
PINION™ PDO and PINION™ PGA-PCL Knotless Sutures are sterile, synthetic, absorbable monofilament sutures featuring unidirectional or bidirectional barbs and attached stainless steel needles. Barbs eliminate the need for manual knot tying during tissue approximation. The device is used by clinicians in surgical settings. The suture is implanted into tissue/bone/blood; it provides wound support during the healing period and is eventually absorbed by the body. The device is MR Safe.
Clinical Evidence
Bench testing only. Performance evaluated per FDA Special Controls Guidance for Surgical Sutures, including USP <861> (diameter), USP <881> (tensile strength), USP <871> (needle attachment), and USP <71> (sterility). Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, hemolysis, and implantation tests. Results met pre-defined acceptance criteria.
Technological Characteristics
Materials: Poly(p-dioxanone) or Poly(glycolide-co-caprolactone). Form: Monofilament with unidirectional/bidirectional barbs (cog shape). Sizes: USP 5-0 to 2 (PDO) and 4-0 to 2 (PGA-PCL). Sterilization: Ethylene Oxide. Connectivity: None. MR Safe.
Indications for Use
Indicated for general soft tissue approximation in patients requiring absorbable sutures.
Regulatory Classification
Identification
An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.
Special Controls
*Classification.* Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
Predicate Devices
- PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture (K232246)
- PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (K232246)
Related Devices
- K232246 — 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture · M/s. Meril Endo Surgery Private Limited. · Apr 25, 2024
- K212810 — MONOFIX PGCL, knotless wound closure device · Samyang Holdings Corp., Ltd. · Aug 5, 2022
- K201139 — WEGO-PDO Barbed Suture · Foosin Medical Supplies Inc., Ltd. · Oct 20, 2020
- K113744 — QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) · Angiotech · Feb 1, 2012
- K242571 — Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 · Hyundae Meditech Co., Ltd. · Sep 27, 2024
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
September 23, 2025
M/s. Meril Endo Surgery Private Limited
Umesh Sharma
Senior General Manager - Quality Assurance/Regulatory Affairs
Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2
Vapi, Gujarat 396191
India
Re: K252644
Trade/Device Name: PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
Regulation Number: 21 CFR 878.4840
Regulation Name: Absorbable Polydioxanone Surgical Suture
Regulatory Class: Class II
Product Code: NEW
Dated: August 18, 2025
Received: August 21, 2025
Dear Umesh Sharma:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252644 - Umesh Sharma
Page 2
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" (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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
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K252644 - Umesh Sharma
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
TEK N. LAMICHHANE -S
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K232246 | ? |
| Please provide the device trade name(s). | | ? |
| PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture;
PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | | |
| Please provide your Indications for Use below. | | ? |
| PINION™ PDO Knotless Suture is indicated for use in general soft tissue approximation where use of an
absorbable suture is appropriate.
PINION™ PGA-PCL Knotless Sutures are indicated for use in soft tissue approximation where use of an
absorbable suture is appropriate. | | |
| Please select the types of uses (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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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
(K252644)
## I. SUBMITTER
M/s. Meril Endo Surgery Private Limited.
Third Floor, E1 – E3, Meril Park,
Survey No. 135/2/B & 174/2, Muktanand Marg,
Chala, Vapi – 396191 Gujarat, India.
Tel. No: +91-260-3052100, Fax: +91-260-3052125
Web site: www.merillife.com
### Applicant Information
Mr. Umesh Sharma
Senior General Manager – Quality Assurance / Regulatory Affairs
E-mail: umesh.sharma@merillife.com
### Primary Correspondent Information
Mr. Umesh Sharma
Senior General Manager – Quality Assurance / Regulatory Affairs
E-mail: umesh.sharma@merillife.com
Date Prepared: September 22nd, 2025
## II. SUBJECT DEVICE
| Trade / Proprietary Name | PINION™ PDO Knotless Suture |
| --- | --- |
| Common Name | Suture, Surgical, Absorbable Polydioxanone |
| Classification | Absorbable Polydioxanone Surgical Suture |
| Regulatory Class | II |
| Product Code | NEW |
| Regulation Number | 21 CFR 878.4840 |
| Review Panel | General & Plastic Surgery Devices Panel |
| Trade / Proprietary Name | PINION™ PGA-PCL Knotless Suture |
| --- | --- |
| Common Name | Suture, Surgical, Absorbable Polyglycolic Acid |
| Classification | Absorbable poly(glycolide/l-lactide) surgical suture |
| Regulatory Class | II |
| Product Code | GAM |
| Regulation Number | 21 CFR 878.4493 |
| Review Panel | General & Plastic Surgery Devices Panel |
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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
## III. PREDICATE DEVICE
| Subject device | Predicate device | | |
| --- | --- | --- | --- |
| | Trade Name/Proprietary Name | Predicate Device Name | 510 (K) No. |
| PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture | PINION™ PDO Knotless Suture | PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture | K232246 |
| PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | PINION™ PGA-PCL Knotless Suture | PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture | K232246 |
## IV. Device Description
### PINION™ PDO KNOTLESS SUTURE
The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots.
PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is $(\mathrm{C_4H_6O_3})_x$. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74.3602) at a level not exceeding $0.3\%$ by weight of the suture in sizes USP (EP) 5-0 (1), 4-0 (1.5), 3-0 (2), 2-0 (3), 0 (3.5), 1 (4) & 2(5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption.
The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PDO Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PDO Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PDO
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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size. The non-barbed size and equivalent size of the PINION™ PDO Knotless Suture is further clarified in Table 1.
The maximum oversize for non barbed suture material from the USP Size is further detailed in Table 2.
The PINION™ PDO Knotless Suture meets requirements established by the United States Pharmacopoeia (USP) for Synthetic absorbable sutures for needle attachments only.
Tensile Strength/Size Equivalency Table 1
| PINION™ PDO Knotless Suture | Pre-Barbing Suture Size | Equivalent Non-barbed Suture Size (USP)/Tensile Strength (kgf) |
| --- | --- | --- |
| 5-0 | 4-0 | 5-0/0.68 |
| 4-0 | 3-0 | 4-0/0.95 |
| 3-0 | 2-0 | 3-0/1.77 |
| 2-0 | 0 | 2-0/2.68 |
| 0 | 1 | 0/3.90 |
| 1 | 2 | 1/5.08 |
| 2 | 3 | 2/6.35 |
Maximum Oversize for non-barbed suture material in diameter (mm) from USP Table 2
| PINION™ PDO Knotless Suture | USP Size Designations (mm) | PINION™ PDO Knotless Suture Diameter Specification (mm) |
| --- | --- | --- |
| 5-0 | 0.100-0.149 | 0.150-0.199 |
| 4-0 | 0.150-0.199 | 0.200-0.249 |
| 3-0 | 0.200-0.249 | 0.300-0.349 |
| 2-0 | 0.300-0.349 | 0.350-0.399 |
| 0 | 0.350-0.399 | 0.400-0.499 |
| 1 | 0.400-0.499 | 0.500-0.599 |
| 2 | 0.500-0.599 | 0.600-0.699 |
The PINION™ PDO Knotless Suture is MR Safe.
# PINION™ PGA-PCL KNOTLESS SUTURE
The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots.
PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone).
PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2), 2-0 (3) 0 (3.5), 1 (4)
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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
& 2(5). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption.
The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PGA-PCL Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PGA-PCL Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size. The non-barbed size and equivalent size of the PINION™ PGA-PCL Knotless Suture is further clarified in Table 1.
The maximum oversize for non barbed suture material from the USP Size is further detailed in Table 2.
The PINION™ PGA-PCL Knotless Suture meets requirements established by the United States Pharmacopoeia (USP) for Synthetic absorbable sutures for needle attachments only.
Tensile Strength/Size Equivalency Table 1
| PINION™ PGA-PCL Knotless Suture | Pre-Barbing Suture Size | Equivalent Non-barbed Suture Size (USP)/Tensile Strength (kgf) |
| --- | --- | --- |
| 4-0 | 3-0 | 4-0/0.95 |
| 3-0 | 2-0 | 3-0/1.77 |
| 2-0 | 0 | 2-0/2.68 |
| 0 | 1 | 0/3.90 |
| 1 | 2 | 1/5.07 |
| 2 | 3 | 2/6.35 |
Maximum Oversize for non-barbed suture material in diameter (mm) from USP Table 2
| PINION™ PGA-PCL Knotless Suture | USP Size Designations (mm) | PINION™ PGA-PCL Knotless Suture Diameter Range (mm) |
| --- | --- | --- |
| 4-0 | 0.150-0.199 | 0.200-0.249 |
| 3-0 | 0.200-0.249 | 0.300-0.349 |
| 2-0 | 0.300-0.349 | 0.350-0.399 |
| 0 | 0.350-0.399 | 0.400-0.499 |
| 1 | 0.400-0.499 | 0.500-0.599 |
| 2 | 0.500-0.599 | 0.600-0.699 |
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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
The PINION™ PGA-PCL Knotless Suture is MR Safe.
## V. Indications for Use
PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
## VI. Comparison of Technological Characteristics with the predicate device
The PINION™ PDO & PINION™ PGA-PCL Knotless Sutures are substantially equivalent to predicate device. The subject device maintain the same intended use, material composition, mechanism of action, fundamental technology, performance characteristics and packaging configuration.
The only modification introduced in this submission is the expansion of available suture sizes. For these additional suture sizes, all testing was performed in accordance with applicable USP and ASTM standards, as well as validated in-house methods, and the results met pre-defined acceptance criteria.
Furthermore, Biological Safety, Shelf-Life and Packaging Integrity, Labeling, and Sterility remain unchanged from the predicate devices, as no modifications were made in these aspects.
Therefore, the expanded size range performs equivalently to the cleared predicate devices and does not raise the questions of safety and effectiveness.
The following characteristics were compared between the subject device and the predicate device in order to demonstrate the substantial equivalence.
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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
The below table provides the comparison of key features of the subject device and predicate devices.
Table 1: PINION™ PDO Knotless Suture
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| 1. | Device Name | PINION™ PDO Knotless Suture | PINION™ PDO Knotless Suture | - |
| 2. | Manufacturer | Meril EndoSurgery Pvt. Ltd. | Meril EndoSurgery Pvt. Ltd. | - |
| 3. | 510(K) Number | - | K232246 | - |
| 4. | Common Name | Absorbable Polydioxanone surgical suture | Absorbable Polydioxanone surgical suture | No change |
| 5. | Class | II | II | No change |
| 6. | Product Code | NEW | NEW | No change |
| 7. | Regulation Number | 21 CFR 878.4840 | 21 CFR 878.4840 | No change |
| 8. | Intended use | PINION™ PDO Knotless Suture is indicated for use in general soft tissue approximation where use of an absorbable suture use is appropriate. | PINION™ PDO Knotless Suture is indicated for use in general soft tissue approximation where use of an absorbable suture use is appropriate. | No Change |
| 9. | Device Description | The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots.
PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p-Polydioxanone). The empirical molecular formula of which is (C₄H₆O₃)ₓ. PINION™ PDO Knotless Sutures are available in | The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots.
PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p-Polydioxanone). The empirical molecular formula of which is (C₄H₆O₃)ₓ. PINION™ PDO Knotless Sutures are available in | Only addition of suture sizes as per USP. |
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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| | | undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 5-0 (1), 4-0 (1.5), 3-0 (2), 2-0 (3), 0 (3.5), 1 (4) & 2(5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption.
The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PDO Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PDO Knotless Suture is identified as one size | undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption.
The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PDO Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PDO Knotless Suture is identified as one size smaller than the non-barbed suture. This | |
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PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| | | smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PDO Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size.
The PINION™ PDO Knotless Suture is MR Safe. | modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PDO Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size.
The PINION™ PDO Knotless Suture is MR Safe. | |
| 10. | For single use only | Single use only | Single use only | No change |
| 11. | Mode of Actions | Two important characteristics describe the in vivo performance of absorbable sutures: first, tensile strength retention and second, the absorption rate (loss of mass). PINION™ PDO Knotless Suture has been formulated to minimize the variability of these characteristics and to provide wound support through the critical wound healing period and an extended healing period.
The in-vitro study indicates that the PINION™ PDO Knotless Suture retains the percentage (%) of its original tensile strength as presented in Table. | Two important characteristics describe the in vivo performance of absorbable sutures: first, tensile strength retention and second, the absorption rate (loss of mass). PINION™ PDO Knotless Suture has been formulated to minimize the variability of these characteristics and to provide wound support through the critical wound healing period and an extended healing period.
The results of in vitro study using PINION™ PDO Knotless Suture indicate that approximately 70-80% of the original strength remains after two weeks and four weeks of study. At six | No change |
Page 8 of 20
{12}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | | | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- | --- | --- |
| | | Table: In-vitro Tensile Strength Profile | | | weeks approximately 40-50% of the original strength is retained. The absorption of PINION™ PDO Knotless Suture is minimal until about 120 days and complete absorption usually takes place within 180 days (six months). | |
| | | Days | Approximate Original Tensile Strength remaining Size 3-0 and larger | Approximate Original Tensile Strength remaining Size 4-0 & Smaller | | |
| | | 14 | 70-80 % | 50-60 % | | |
| | | 28 | 70-80 % | 40-50 % | | |
| | | 42 | 40-50 % | 15-35 % | | |
| | | The absorption of PINION™ PDO Knotless Suture is minimal until about 120 days and complete absorption usually takes place within 180 days (six months). | | | | |
| 12. | Material composition | poly (p-dioxanone) | | | poly (p-dioxanone) | No change |
| 13. | Body Contact | Tissue/Bone/Blood | | | Tissue/Bone/Blood | No change |
| 14. | Shelf Life | 5 Year | | | 5 Year | No change |
| 15. | USP Sizes (Size availability) | 5-0 to 2 | | | 3-0 to 0 | The extended range of the suture size is in accordance with USP. |
| 16. | Absorbable/Non Absorbable | Absorbable | | | Absorbable | No change |
| 17. | Braided/ | Monofilament | | | Monofilament | No change |
{13}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | | Predicate Device | | Safety / Effectiveness |
| --- | --- | --- | --- | --- | --- | --- |
| | Monofilament | | | | | |
| 18. | Dyed / Undyed | Undyed or Dyed Suture Strands | | Undyed or Dyed Suture Strands | | No change |
| 19. | Colorant | D&C Violet No. 2 | | D&C Violet No. 2 | | No change |
| 20. | Coated / Uncoated | Uncoated | | Uncoated | | No change |
| 21. | Types of Barbs | Uni-directional, Bi-directional | | Uni-directional, Bi-directional | | No change |
| 22. | Barb Angle | 5-0 | 45-55(∠°) | - | - | The extended range of the suture size is in accordance with USP. Additional testing is conducted for additional sizes. |
| | | 4-0 | 58-63 (∠°) | - | - | |
| | | 3-0 | 35-45 (∠°) | 3-0 | 35-45 (∠°) | |
| | | 2-0 | 40-50 (∠°) | 2-0 | 40-50 (∠°) | |
| | | 0 | 35-45 (∠°) | 0 | 35-45 (∠°) | |
| | | 1 | 45-55(∠°) | - | - | |
| | | 2 | 45-55(∠°) | - | - | |
| 23. | Barb Height | 5-0 | 0.200-0.300 mm | - | - | The extended range of the suture size is in accordance with USP. Additional testing is conducted for additional sizes. |
| | | 4-0 | 0.258-0.283 mm | - | - | |
| | | 3-0 | 0.250-0.350 mm | 3-0 | 0.250-0.350 mm | |
| | | 2-0 | 0.300-0.400 mm | 2-0 | 0.300-0.400 mm | |
| | | 0 | 0.350-0.450 mm | 0 | 0.350-0.450 mm | |
| | | 1 | 0.400-0.500 mm | - | - | |
| | | 2 | 0.450-0.550 mm | - | - | |
| 24. | Barb Shape | Cog Shape | | Cog Shape | | No change |
| 25. | Barb Direction (Bidirectional) | A section and B section in opposite direction. | | A section and B section in opposite direction. | | No change |
| 26. | Barb Direction (Unidirectional) | A section and B section in same direction. | | A section and B section in same direction. | | No change |
| 27. | Complete Absorption | within 180 to 210 days | | within 180 to 210 days | | No change |
| 28. | Sterilization method | Ethylene Oxide | | Ethylene Oxide | | No change |
Page 10 of 20
{14}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| 29. | Needle Material | Stainless Steel | Stainless Steel | No change |
| 30. | Packaging | *Primary Packaging* – Suture is wound on plastic tray and further packed in Aluminium Foil and Sealed in Tyvek lid.
*Secondary Packaging* – Primary packed suture are placed in Dispenser Box. | *Primary Packaging* – Suture is wound on plastic tray and further packed in Aluminium Foil and Sealed in Tyvek lid.
*Secondary Packaging* – Primary packed suture are placed in Dispenser Box. | No change |
| 31. | Label Claim | Complies with the requirements of the United States Pharmacopoeia for “Synthetic Absorbable Surgical Suture” (except for diameter) | Complies with the requirements of the United States Pharmacopoeia for “Synthetic Absorbable Surgical Suture” (except for diameter) | No change |
| 32. | Diameter USP <861> | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Diameter<861>, except for diameter for some oversize suture. | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Diameter<861>, except for diameter for some oversize suture. | No change |
| | Tensile strength USP <881> | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Tensile strength <881>. | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Tensile strength <881>. Straight Tensile meets USP Knot Tensile requirements for Synthetic Absorbable Sutures for same suture size equivalent. | No change |
| | Needle attachment USP <871> | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Needle attachment <871>. | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Needle attachment <871>. | No change |
| 33. | Labeling and Instructions | Labeling conforming to 21CFR 801.109 | Labeling conforming to 21CFR 801.109 | No change |
Page 11 of 20
{15}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| | for use (IFU). | and USP.
IFU includes indications, warnings, adverse reactions, Contraindication and precautions. | and USP.
IFU includes indications, warnings, adverse reactions, Contraindication and precautions | |
| 34. | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | No change |
Table 2: PINION™ PGA-PCL Knotless Suture
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| 1. | Device Name | PINION™ PGA PCL Knotless Suture | PINION™ PGA PCL Knotless Suture | - |
| 2. | Manufacturer | Meril EndoSurgery Pvt. Ltd. | Meril EndoSurgery Pvt. Ltd. | - |
| 3. | 510(K) Number | - | 232246 | - |
| 4. | Common Name | Absorbable poly(glycolide/l-lactide) surgical suture | Absorbable poly(glycolide/l-lactide) surgical suture | No change |
| 5. | Class | II | II | No change |
| 6. | Product Code | GAM | GAM | No change |
| 7. | Regulation Number | 21 CFR 878.4493 | 21 CFR 878.4493 | No change |
| 8. | Intended use | PINION™ PGA PCL Knotless Suture is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. | PINION™ PGA PCL Knotless Suture is indicated for use in soft tissue approximation where the use of absorbable suture is appropriate. | No change |
| 9. | Device Description | The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. | The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots.
PINION™ PGA-PCL Knotless Suture is a sterile, | Only addition of suture sizes as per USP. |
Page 12 of 20
{16}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| | | PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone).
PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74.3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2), 2-0 (3) 0 (3.5), 1 (4) & 2(5). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption.
The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PGA-PCL Knotless Suture is identified as one size smaller | synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone).
PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74.3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption.
The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PGA-PCL Knotless Suture is identified as one size smaller | |
Page 13 of 20
{17}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| | | needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.
The USP designations for diameter are applicable to the PINION™ PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PGA-PCL Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PGA-PCL Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size.
The PINION™ PGA-PCL Knotless Suture is MR Safe. | than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PGA-PCL Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size.
The PINION™ PGA-PCL Knotless Suture is MR Safe. | |
| 10. | For single use only | Single use only | Single use only | No change |
| 11. | Mode of Actions | Two important characteristics describe the in vivo performance of absorbable sutures: first, tensile strength retention and second, the absorption rate (loss of mass). | Two important characteristics describe the in vivo performance of absorbable sutures: first, tensile strength retention and second, the absorption rate (loss of mass). PINION™ PGA PCL Knotless Suture has been formulated to | No change |
Page 14 of 20
{18}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | | | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- | --- | --- |
| | | PINION™ PGA PCL Knotless Suture
Knotless Suture has been
formulated to minimize the
variability of these characteristics
and to provide wound support
through the critical wound healing
period and an extended healing period.
The In-vitro study indicates that
the PINION™ PGA-PCL Knotless
Suture retains the percentage (%)
of its original tensile strength as
presented in Table.
Table: In-vitro Tensile Strength
Profile | | | minimize the variability of these characteristics
and to provide wound support through the
critical wound healing period and an extended
healing period.
PINION™ PGA PCL Knotless Suture retains
approximately 62 % of its original strength 7
days post implantation and approximately 46 %
of its original tensile strength at 14 days post
implantation all of the original tensile strength
is lost by 28 days post implantation.
The absorption of PINION™ PGA-PCL Knotless
Suture is essentially completed between 90
and 120 days. | |
| | | Approximate
Original
Tensile
Strength
remaining
Sizes 3-0 and
larger | Approximate
Original
Tensile
Strength
remaining
Size 4-0 | | | |
| | | Days | Days | | | |
| | | 7 | 62 % | 7 | 60 % | |
| | | 14 | 46 % | 14 | 42 % | |
| All of the
original tensile
strength is
essentially lost | | All of the
original tensile
strength is
essentially lost | | | | |
Page 15 of 20
{19}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | | Predicate Device | | Safety / Effectiveness |
| --- | --- | --- | --- | --- | --- | --- |
| | | by 28 days. | by 21 days. | | | |
| | | The absorption of PINION™ PGA-PCL Knotless Suture is essentially completed between 90 and 120 days. | | | | |
| 12. | Material composition | Copolymer of (glycolide and ε carprolactone)(PGA-PCL) | | Copolymer of (glycolide and ε carprolactone)(PGA-PCL) | | No change |
| 13. | Body Contact | Tissue/Bone/Blood | | Tissue/Bone/Blood | | No change |
| 14. | Shelf Life | 5 Year | | 5 Year | | No change |
| 15. | Size availability | 4-0 to 2 | | 4-0 to 2-0 | | The extended range of the suture size is in accordance with USP. |
| 16. | Absorbable/Non Absorbable | Absorbable | | Absorbable | | No change |
| 17. | Braided/ Monofilament | Monofilament | | Monofilament | | No change |
| 18. | Dyed / Undyed | Undyed or Dyed Suture Strands | | Undyed or Dyed Suture Strands | | No change |
| 19. | Colorant (if Dyed) | D&C Violet No. 2 | | D&C Violet No. 2 | | No change |
| 20. | Coated / Uncoated | Uncoated | | Uncoated | | No change |
| 21. | Types of Barbs | Uni-directional, Bi-directional | | Uni-directional, Bi-directional | | No change |
| 22. | Barb Angle | 4-0 | 58-63 (∠°) | 4-0 | 58-63 (∠°) | The extended range of the suture size is in accordance with USP. Additional testing is conducted for additional sizes. |
| | | 3-0 | 35-45 (∠°) | 3-0 | 35-45 (∠°) | |
| | | 2-0 | 40-50 (∠°) | 2-0 | 40-50 (∠°) | |
| | | 0 | 35-45 (∠°) | - | - | |
| | | 1 | 45-55(∠°) | - | - | |
| | | 2 | 45-55(∠°) | - | - | |
| 23. | Barb Height | 4-0 | 0.253-0.283 mm | 4-0 | 0.253-0.283 mm | The extended range of the suture size is in |
| | | 3-0 | 0.250-0.350 mm | 3-0 | 0.250-0.350 mm | |
| | | 2-0 | 0.300-0.400 mm | 2-0 | 0.300-0.400 mm | |
Page 16 of 20
{20}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | | Predicate Device | | Safety / Effectiveness |
| --- | --- | --- | --- | --- | --- | --- |
| | | 0 | 0.350-0.450 mm | - | - | accordance with USP. Additional testing is conducted for additional sizes. |
| | | 1 | 0.400-0.500 mm | - | - | |
| | | 2 | 0.450-0.550 mm | - | - | |
| 24. | Barb Shape | Cog Shape | | Cog Shape | | No change |
| 25. | Barb Direction (Bidirectional) | A section and B section in opposite direction. | | A section and B section in opposite direction. | | No change |
| 26. | Barb Direction (Unidirectional) | A section and B section in same direction. | | A section and B section in same direction. | | No change |
| 27. | Absorption Profile | between 90 and 120 days. | | between 90 and 120 days. | | Identical |
| 28. | Sterilization method | Ethylene Oxide | | Ethylene Oxide | | Identical |
| 29. | Needle Material | Stainless Steel | | Stainless Steel | | Identical |
| 30. | Packaging Configuration | *Primary Packaging* – Suture is wound on plastic tray and further packed in Aluminium Foil and Sealed in Tyvek lid.
*Secondary Packaging* – Primary packed suture are placed in Dispenser Box. | | *Primary Packaging* – Suture is wound on plastic tray and further packed in Aluminium Foil and Sealed in Tyvek lid.
*Secondary Packaging* – Primary packed suture are placed in Dispenser Box. | | No Change |
| 31. | Label Claim | Complies with the requirements of the United States Pharmacopoeia for “Synthetic Absorbable Surgical Suture” (except for diameter) | | Complies with the requirements of the United States Pharmacopoeia for “Synthetic Absorbable Surgical Suture” (except for diameter) | | No Change |
| 32. | | | | | | |
| | Diameter USP <861> | Finished suture material meets the performance requirements defined in the United States Pharmacopoeia for Diameter<861>, except for diameter for some oversize suture. | | Finished suture material meets the performance requirements defined in the United States Pharmacopoeia for Diameter<861>, except for diameter for some oversize suture. | | No change |
| | Tensile strength USP <881> | Finished suture material meets the performance requirements defined | | Finished suture material meets the performance requirements defined in the | | No change |
Page 17 of 20
{21}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
510(K) SUMMARY
| Sr. No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness |
| --- | --- | --- | --- | --- |
| | | in the United States Pharmacopeia for Tensile strength <881>. Straight Tensile meets USP Knot Tensile requirements for Synthetic Absorbable Sutures for same suture size equivalent. | United States Pharmacopeia for Tensile strength <881>. Straight Tensile meets USP Knot Tensile requirements for Synthetic Absorbable Sutures for same suture size equivalent. | |
| | Needle attachment USP <871> | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Needle attachment <871>. | Finished suture material meets the performance requirements defined in the United States Pharmacopeia for Needle attachment <871>. | No change |
| 33. | Labeling and Instructions for use (IFU). | Labeling conforming to 21CFR 801.109 and USP. IFU includes indications, warnings, adverse reactions, Contraindication and precautions. | Labeling conforming to 21CFR 801.109 and USP. IFU includes indications, warnings, adverse reactions, Contraindication and precautions | No change |
| 34. | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | No change |
Page 18 of 20
{22}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
## VII. Preclinical Data
### Performance Tests
The PINION™ PDO & PINION™ PGA-PCL Knotless Sutures were subjected to the performance testing as per FDA's Special Control Guidance Document for Surgical Sutures, “Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff June 2, 2003” performance testing including testing in accordance to USP for Absorbable suture and biocompatibility testing of the suture material in accordance to EN ISO 10993-1:2020 has been performed to further ensure substantial equivalence to the predicate devices. The safety and effectiveness of the PINION™ PDO & PINION™ PGA-PCL Knotless Sutures have been evaluated for the following performance and safety requirements.
1. Diameter USP <861>
2. Tensile strength USP <881>
3. Needle attachment USP <871>
4. Suture Length
5. Number of barbs per linear length of suture
6. Barb size (length)
7. Barb size Direction
8. Barb Angle
9. Barb holding strength
10. Sterility USP <71>
11. Biocompatibility as per ISO 10993-1
12. Suture Resorption Profile
### Biocompatibility
The biocompatibility evaluation for PINION™ PDO & PINION™ PGA-PCL Knotless Suture was conducted in accordance with Guidance document ‘Use of International Standard ISO 10993-1, “Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” September 8, 2023 and International Standards ISO 10993-1 “Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process” as recognized by FDA. Biocompatibility testing performed on suture material type for implantable material included Cytotoxicity, Skin Sensitization, Irritation test, Systemic Toxicity, Genotoxicity Study, In vitro Haemolysis test, Implantation test, Material mediated Pyrogenicity, Chronic Toxicity and Carcinogenicity. The risk assessment for chronic toxicity and carcinogenicity for subject device was evaluated based on the previously 510(K) cleared device (K172659).
The test results and risk assessment suggests that the subject device is biocompatible.
{23}
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures 510(K)
# 510(K) SUMMARY
## VIII. Conclusion
PINION™ PDO & PINION™ PGA-PCL Knotless Sutures are substantially equivalent to currently marketed device and present no substantial differences in design, material, intended use and function to predicate device.
The performance, biocompatibility, sterilization, packaging and shelf life study conducted on PINION™ PDO & PINION™ PGA-PCL Knotless Sutures demonstrated the device is as safe and as effective as the predicate device. Hence, PINION™ PDO & PINION™ PGA-PCL Knotless Sutures will perform as intended in the specified use conditions.
Page 20 of 20
