510(k) · Cleared
Recalled · Class II · 2024Depuy Synthes Injectable Polymer System (Ips)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Synthes Companies of Johnson & Johnson · HBW Fastener, Plate, Cranioplasty
Cleared on Mar 27, 2015 as substantially equivalent to K050204 (Synthes (Usa), 2005) and 3 other predicates after a 304-day review. Its family tree reaches back 8 generations to 1990. It has been recalled once.
- Decided
- Mar 27, 2015
- Review
- 304 days
- Class
- Class II
- Product code
- HBW
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 8 generations to K904436 (1990). 32 ancestors in all, the oldest K900138 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 6 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 5 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 4 generations backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- 3 generations backK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- 2 generations backK051236 Resorb-X SFKLS-Martin L.P. · 2005
- 1 generation backK080862 Sonicweld RX (Resorb-X)KLS-Martin L.P. · 2008
- This deviceK141385 Depuy Synthes Injectable Polymer System (Ips)Depuy Synthes Companies of Johnson & Johnson · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −7 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −6 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −5 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −4 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| −3 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| −2 | K051236 | Resorb-X SF | KLS-Martin L.P. | 2005 | — |
| −1 | K080862 | Sonicweld RX (Resorb-X) | KLS-Martin L.P. | 2008 | — |
| 0 (this device) | K141385 | Depuy Synthes Injectable Polymer System (Ips) | Depuy Synthes Companies of Johnson & Johnson | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 HBW? 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 HBW device
- #1 K251472 Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation…score 10.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K050204 | Synthes Rapid Resorbable Tack SystemSummary page 4…ode: HBW Common Name: Cranioplasty Plate Fastener Predicate Devices: (Please see Table 1, below) Synthes (USA) Rapid Resorbable Tack System (K050204) Synthes (USA) Rapid Resorbable Fixation System (K062789) (Principal Pred… | 2005 |
| * | K062789 | Synthes (Usa) Rapid Resorbable Fixation SystemSummary page 4…ate Devices: (Please see Table 1, below) Synthes (USA) Rapid Resorbable Tack System (K050204) Synthes (USA) Rapid Resorbable Fixation System (K062789) (Principal Predicate) KLS-Martin, L.P., SonicWeld RX (Resorb- X) (K08086… | 2007 |
| * | K080862 | Sonicweld RX (Resorb-X)Summary page 4…USA) Rapid Resorbable Fixation System (K062789) (Principal Predicate) KLS-Martin, L.P., SonicWeld RX (Resorb- X) (K080862) Biomet Inc., Lactosorb Trauma Plating System (K992355) Indications for Use: The RAPIDSORB Inj… | 2008 |
| * | K992355 | Lactosorb Trauma Plating SystemSummary page 4…pal Predicate) KLS-Martin, L.P., SonicWeld RX (Resorb- X) (K080862) Biomet Inc., Lactosorb Trauma Plating System (K992355) Indications for Use: The RAPIDSORB Injectable Polymer System (IPS) is indicated for use in non… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 24, 2024 | Class II | Z-1238-2024 | Process control | Products not sterilized, sterility cannot be confirmed |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 32 ancestors have a recall of any class.
- 1 other device also cites its predicate K050204.
How does its category compare?
All HBW devicesHBW Fastener, Plate, Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HBW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBW
Too few HBW 510(k)s in any year since 2007 to give a median.
Recalls per year · HBW
No recall names HBW since 2007.
Adverse event reports per year · HBW
3in 2025
MAUDE reports naming product code HBW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, meshes, and sheets.
In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets 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 craniofacial reconstruction (excluding the upper and lower jaw).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141385: Depuy Synthes Injectable Polymer System (Ips).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141385
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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