510(k) · Cleared
ClearedResorb-X G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · GWO Plate, Cranioplasty, Preformed, Alterable
Cleared on Jan 17, 2013 as substantially equivalent to K073006 (Takiron Co., Ltd., 2008) and 4 other predicates after a 230-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Jan 17, 2013
- Review
- 230 days
- Class
- Class II
- Product code
- GWO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K904436 (1990). 67 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations between
- 3 generations backK051236 Resorb-X SFKLS-Martin L.P. · 2005
- 2 generations backK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- 1 generation backK112064 Resorb X-GKLS-Martin L.P. · 2012
- This deviceK121606 Resorb-X GKLS-Martin L.P. · 2013
Show all 9 generations
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 8 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 7 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 6 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 5 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 4 generations backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- 3 generations backK051236 Resorb-X SFKLS-Martin L.P. · 2005
- 2 generations backK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- 1 generation backK112064 Resorb X-GKLS-Martin L.P. · 2012
- This deviceK121606 Resorb-X GKLS-Martin L.P. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −8 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −7 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −6 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −5 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −4 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| −3 | K051236 | Resorb-X SF | KLS-Martin L.P. | 2005 | — |
| −2 | K080862 | Sonicweld RX (Resorb-X) | KLS-Martin L.P. | 2008 | — |
| −1 | K112064 | Resorb X-G | KLS-Martin L.P. | 2012 | — |
| 0 (this device) | K121606 | Resorb-X G | KLS-Martin L.P. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 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 GWO? 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 GWO device
- #1 K261058 CraniUS Platescore 16.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation SystemSummary page 1…Cranioplasty plate fastener Class 11, 21 CFR 882.5360, Product Code HBW Predicate Devices: OSTEOTRANSTM-MX (K073006) Resorb-X G (K(112064) Synthes Rapid Resorbable Fixation System (K(… | 2008 |
| * | K112064 | Resorb X-GSummary page 1…Class 11, 21 CFR 882.5360, Product Code HBW Predicate Devices: OSTEOTRANSTM-MX (K073006) Resorb-X G (K(112064) Synthes Rapid Resorbable Fixation System (K(062789) LactoSorb Trau… | 2012 |
| * | K062789 | Synthes (Usa) Rapid Resorbable Fixation SystemSummary page 1…es: OSTEOTRANSTM-MX (K073006) Resorb-X G (K(112064) Synthes Rapid Resorbable Fixation System (K(062789) LactoSorb Trauma Plating System (K(992355) Sonic Weld RX (Resorb-X… | 2007 |
| * | K992355 | Lactosorb Trauma Plating SystemSummary page 1…esorb-X G (K(112064) Synthes Rapid Resorbable Fixation System (K(062789) LactoSorb Trauma Plating System (K(992355) Sonic Weld RX (Resorb-X) (K(080862) Device Description: The Resorb-X G product line consists of… | 1999 |
| * | K080862 | Sonicweld RX (Resorb-X)Summary page 1…gical site and utilize the micro undercuts of the bone for retention. The plate, mesh and pin sizes and configurations are identical to components previously cleared in K080862, SonicWeld RX (Resorb-X). The PLLA/PGA material is identical to that cleared in KI 12064, Resorb-X G. This premarket notification… | 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 23 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 8 of the 67 ancestors have a recall of any class.
- 1 other device also cites its predicate K073006.
How does its category compare?
All GWO devicesGWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GWO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWO
196in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWO
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWO
237in 2025
MAUDE reports naming product code GWO, 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 | 1 | — | 1 | 0 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 5 | 133 | 0 | 5 |
| 2013 | 4 | 249 | 0 | 7 |
| 2014 | 3 | 109 | 0 | 11 |
| 2015 | 3 | 210 | 2 | 18 |
| 2016 | 3 | 125 | 0 | 18 |
| 2017 | 2 | — | 0 | 47 |
| 2018 | 1 | — | 0 | 41 |
| 2019 | 4 | 196 | 0 | 14 |
| 2020 | 0 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 2 | — | 0 | 53 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 149 |
| 2025 | 2 | — | 0 | 237 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in pediatric and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in cranial reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121606: Resorb-X G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121606
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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