# K061037: PDS Plus Antibacterial Suture

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 14, 2006 after 91 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960653 (1996). 4 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032420: Modified Coated Vicryl Plus Antibacterial (Polyglactin 910) Synthetic Absorbable Suture, ETHICON, Inc. (2003) Summary page 1.
- K050845: Monocryl Plus Antibacterial Suture, ETHICON, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K018331: PDS II (Polydioxanone) Suture. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K150670: STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (2015), 8 descendants of its own
- K182873: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices (2019), 7 descendants of its own
- K100461: PDM, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic Gut (2010), 5 descendants of its own
- K221744: STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (2022), 2 descendants of its own
- K212380: PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture (2022), 2 descendants of its own

## Recalls of this device
- May 10, 2024 · Class II · Z-2147-2024: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- Mar 31, 2023 · Class II · Z-1571-2023: Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
- Mar 12, 2019 · Class II · Z-1135-2019: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
- Jun 8, 2018 · Class II · Z-2533-2018: Products do not meet a tensile strength specification
- Jun 8, 2018 · Class II · Z-2532-2018: Products do not meet a tensile strength specification
- Jan 10, 2018 · Class II · Z-1340-2018: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of 
- Jan 10, 2018 · Class II · Z-1338-2018: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of 
- Jan 10, 2018 · Class II · Z-1339-2018: Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of 
- Feb 2, 2009 · Not classified · Z-1314-2009: Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.

## Indications for use
PDS* Plus Antibacterial monofilament synthetic absorbable sutures are indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS Plus is not indicated in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

Source page: https://510kreport.com/device/K061037
Methodology: https://510kreport.com/methodology