510(k) · Cleared
ClearedThe Trabecular Metal Reconstruction System, Model 10-340-Xxxxx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implex Corp. · FTM Mesh, Surgical
Cleared on Jul 14, 2004 as substantially equivalent to K032344 (Implex Corp., 2003) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Jul 14, 2004
- Review
- 112 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K023882 (2003). 3 ancestors in all, the oldest K962468 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK023882 The Hedrocel Trabecular Metal Reconstruction SystemImplex Corp. · 2003
- 1 generation backK032344 The Hedrocel Trabecular Metal Reconstruction System Model 10-330Implex Corp. · 2003
- This deviceK040756 The Trabecular Metal Reconstruction System, Model 10-340-XxxxxImplex Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023882 | The Hedrocel Trabecular Metal Reconstruction System | Implex Corp. | 2003 | — |
| −1 | K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330 | Implex Corp. | 2003 | — |
| 0 (this device) | K040756 | The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx | Implex Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330Summary page 1….5mm in diameter. The components of this line extension are wedge-shaped components, similar to the cleared wedge-shapes (K032344). The smallest size wedge is 19mm height with a 50 angle and the largest size wedge is… | 2003 |
| Kept off the family tree | K023388 | FDA’s K023388 is Mitek Rapidloc-PDS Meniscal Repair System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | K962468 | Hedrocel Acetabular RestrictorSummary page 2…ards were performed for the predicate devices described in K02388, Master File MAF #920, and other mechanical testing reported in K962468. These results indicate that the subject device will perform as indicated for use in support of weakened… | 1997 |
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 1 year and passes through 1 company; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K032344.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Trabecular Metal Reconstruction System may also be used with bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040756: The Trabecular Metal Reconstruction System, Model 10-340-Xxxxx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040756
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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