510(k) · Cleared
ClearedRexmono, Pdrex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sm Eng Co., Ltd. · GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Cleared on Mar 12, 2018 as substantially equivalent to K142810 (Foosin Medical Supplies Inc., Ltd., 2014) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 2002.
- Decided
- Mar 12, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- GAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K014153 (2002). 34 ancestors in all, the oldest K900198 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK014153 Coapt Systmes Endotine DeviceCoapt Systems, Inc. · 2002
- 7 generations backK023922 Coapt Systems Endotine Device, Model CFD-101-00197Coapt Systems, Inc. · 2002
- 6 generations backK032698 Coapt Endotine Midface-ST 4.5 DeviceCoapt Systems, Inc. · 2003
- 5 generations backK041593 Featherlift Extended Length Aptos ThreadSurgical Specialties Corp · 2004
- 4 generations backK050548 Contour Midface Opposing Uni-Directional ThreadsSurgical Specialties Corp · 2005
- 3 generations backK051609 Quill Synthetic Absorbable Barbed SutureQuill Medical, Inc. · 2005
- 2 generations backK053380 Contour Thread Synthetic Absorbable Pdo Barbed SutureSurgical Specialties Corp · 2006
- 1 generation backK073614 WG-Surgical Sutures with NeedleFoosin Medical Supplies, Inc. · 2008
- This deviceK173779 Rexmono, PdrexSm Eng Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K014153 | Coapt Systmes Endotine Device | Coapt Systems, Inc. | 2002 | — |
| −7 | K023922 | Coapt Systems Endotine Device, Model CFD-101-00197 | Coapt Systems, Inc. | 2002 | — |
| −6 | K032698 | Coapt Endotine Midface-ST 4.5 Device | Coapt Systems, Inc. | 2003 | — |
| −5 | K041593 | Featherlift Extended Length Aptos Thread | Surgical Specialties Corp | 2004 | — |
| −4 | K050548 | Contour Midface Opposing Uni-Directional Threads | Surgical Specialties Corp | 2005 | — |
| −3 | K051609 | Quill Synthetic Absorbable Barbed Suture | Quill Medical, Inc. | 2005 | — |
| −2 | K053380 | Contour Thread Synthetic Absorbable Pdo Barbed Suture | Surgical Specialties Corp | 2006 | — |
| −1 | K073614 | WG-Surgical Sutures with Needle | Foosin Medical Supplies, Inc. | 2008 | — |
| 0 (this device) | K173779 | Rexmono, Pdrex | Sm Eng Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GAM device
- #1 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue…score 14.8 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K142810 | WEGO-PGCL Absorbable Surgical Monofilament SutureSummary page 6…cardiovascular tissue, microsurgery, ophthalmic and neural tissue. ● Predicate Device Identification 1. REXMONO -Predicate Device 510(k) Number: K142810 Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD 2. P… | 2014 |
| * | K073614 | WG-Surgical Sutures with NeedleSummary page 6…ce Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD 2. PDREX -Predicate Device 510(k) Number: K073614 Device Name: WG-Surgical Sutures with Needle Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 12 of the 34 ancestors have a recall of any class.
How does its category compare?
All GAM devicesGAM Suture, Absorbable, Synthetic, Polyglycolic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GAM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GAM
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAM
8,970in 2025
MAUDE reports naming product code GAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 50 | 10 | 274 |
| 2008 | 6 | 174 | 1 | 194 |
| 2009 | 3 | 10 | 6 | 287 |
| 2010 | 1 | — | 3 | 587 |
| 2011 | 2 | — | 6 | 637 |
| 2012 | 5 | 31 | 0 | 868 |
| 2013 | 1 | — | 0 | 898 |
| 2014 | 10 | 121 | 0 | 1,410 |
| 2015 | 5 | 209 | 0 | 935 |
| 2016 | 3 | 169 | 1 | 1,112 |
| 2017 | 8 | 134 | 1 | 1,499 |
| 2018 | 5 | 98 | 0 | 2,229 |
| 2019 | 4 | 90 | 1 | 3,564 |
| 2020 | 3 | 140 | 44 | 3,415 |
| 2021 | 2 | — | 0 | 4,506 |
| 2022 | 2 | — | 4 | 4,814 |
| 2023 | 1 | — | 0 | 5,070 |
| 2024 | 2 | — | 1 | 7,226 |
| 2025 | 3 | 29 | 0 | 8,970 |
| 2026 | 4 | 131 | 2 | — |
What is it indicated for?
REXMONO is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not
for use in cardiovascular or neural tissue.
PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected
to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173779: Rexmono, Pdrex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173779
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026