510(k) · Cleared
ClearedOrthomesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Jul 15, 2008 as substantially equivalent to K033918 (Ebi, L.P., 2004) and 9 other predicates after a 253-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it.
- Decided
- Jul 15, 2008
- Review
- 253 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 3 generations to K974017 (1998). 16 ancestors in all, the oldest K960988 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
- 2 generations backK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
- 1 generation backK033918 Ebi Lactosorb Graft Containment SystemEbi, L.P. · 2004
- This deviceK073115 OrthomeshSynthes (Usa) · 2008
- Descendant · cites it directly · 0 of its ownK180821 TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K180821TruMatch Graft Cage - Long BoneSynthes (Usa), LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974017 | Timesh System | Sofamor Danek USA,Inc. | 1998 | 1 |
| −2 | K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | 2000 | — |
| −1 | K033918 | Ebi Lactosorb Graft Containment System | Ebi, L.P. | 2004 | — |
| 0 (this device) | K073115 | Orthomesh | Synthes (Usa) | 2008 | — |
| +1 | K180821 | TruMatch Graft Cage - Long Bone | Synthes (Usa), LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K033918 | Ebi Lactosorb Graft Containment SystemSummary page 1…assification Codes: HRS, Plate, Fixation, Bone; HWC, Screw, Fixation, Bone. Predicate Device: EBI LactoSorb® Graft Containment System (K03391 8), Synthes Resorbable Meshes and Sheets (K003788), W. Lorenz LactoSorbg Trauma… | 2004 |
| * | K003788 | Synthes Resorable Meshes and SheetsSummary page 1…WC, Screw, Fixation, Bone. Predicate Device: EBI LactoSorb® Graft Containment System (K03391 8), Synthes Resorbable Meshes and Sheets (K003788), W. Lorenz LactoSorbg Trauma Plating System ((Biomet) K960988, K97 1870, K99… | 2001 |
| * | K960988 | Lactosorb Trauma Plating SystemSummary page 1…Synthes Resorbable Meshes and Sheets (K003788), W. Lorenz LactoSorbg Trauma Plating System ((Biomet) K960988, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069,… | 1996 |
| * | K971870 | Lactosorb Trauma Plating SystemSummary page 1…Synthes Resorbable Meshes and Sheets (K003788), W. Lorenz LactoSorbg Trauma Plating System ((Biomet) K960988, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069,… | 1997 |
| * | K992158 | Lactosorb SheetsSummary page 1…nthes Resorbable Meshes and Sheets (K003788), W. Lorenz LactoSorbg Trauma Plating System ((Biomet) K960988, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069,… | 1999 |
| * | K003281 | Lactosorb RapidflapSummary page 1…le Meshes and Sheets (K003788), W. Lorenz LactoSorbg Trauma Plating System ((Biomet) K960988, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069, K04161 1, K05… | 2001 |
| * | K030069 | Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation SystemSummary page 1…ting System ((Biomet) K960988, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069, K04161 1, K050204, K062789). Intended Use: The Synthes Ortho~lesh Resorbable Graft Contai… | 2003 |
| * | K041611 | Synthes (Usa) Rapid Resorbable Cranial ClampSummary page 1…K960988, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069, K04161 1, K050204, K062789). Intended Use: The Synthes Ortho~lesh Resorbable Graft Containment syst… | 2004 |
| * | K050204 | Synthes Rapid Resorbable Tack SystemSummary page 1…K960988, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069, K04161 1, K050204, K062789). Intended Use: The Synthes Ortho~lesh Resorbable Graft Containment system is ind… | 2005 |
| * | K062789 | Synthes (Usa) Rapid Resorbable Fixation SystemSummary page 1…, K97 1870, K992 158, and K00328 1), and Synthes (USA) Rapid Resorbable Fixation System (K03 0069, K04161 1, K050204, K062789). Intended Use: The Synthes Ortho~lesh Resorbable Graft Containment system is indicated fo… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180821 | TruMatch Graft Cage - Long Bone | 2018 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K180821 (Synthes (Usa), LLC, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K033918.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Synthes OrthoMesh Resorbable Graft Containment system is indicated for use in maintaining the relative position of weak bony tissue such as bone grafts, bone graft substitutes or bone fragments from comminuted fractures. OrthoMesh implants may be used alone (without traditional rigid fixation) to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in non-load-bearing reconstructive procedures involving areas where…
Read the full statement (152 words)
The Synthes OrthoMesh Resorbable Graft Containment system is indicated for use in maintaining the relative position of weak bony tissue such as bone grafts, bone graft substitutes or bone fragments from comminuted fractures.
OrthoMesh implants may be used alone (without traditional rigid fixation) to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in non-load-bearing reconstructive procedures involving areas where bone stability has not been compromised, such as tumor resections and iliac crest graft harvest sites.
OrthoMesh implants must be used in conjunction with traditional rigid fixation in load bearing applications to maintain the relative position of bone grafts, bone graft substitutes or bone fragments in reconstructive procedures involving long bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax. These devices are not intended for use in the spine. The devices are not intended for load bearing indications unless used in conjunction with traditional rigid fixation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073115: Orthomesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073115
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