510(k) · Cleared
ClearedTrokabone, Trokabone Sternal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · FCG Biopsy Needle
Cleared on Mar 7, 2007 as substantially equivalent to K013692 (H.S. Hospital Service S.R.L., 2002) and 1 other predicate after a 47-day review. Its family tree reaches back 6 generations to 1987. 1 of the 22 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 7, 2007
- Review
- 47 days
- Class
- Class II
- Product code
- FCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K871390 (1987). 21 ancestors in all. No later device cites it as a predicate yet. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 5 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
- 4 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
- 3 generations backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
- 2 generations backK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
- 1 generation backK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- This deviceK070179 Trokabone, Trokabone SternalPAJUNK GmbH Medizintechnologie · 2007
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow2 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −5 | K962969 | Medical Device Technologies, Inc.Ultra | Medical Device Technologies, Inc. | 1996 | — |
| −4 | K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy… | Medical Device Technologies, Inc. | 1998 | — |
| −3 | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument | Medical Device Technologies, Inc. | 1998 | 2 |
| −2 | K990839 | Tru-Core I Reusable Biopsy Instrument | Medical Device Technologies, Inc. | 1999 | — |
| −1 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| 0 (this device) | K070179 | Trokabone, Trokabone Sternal | PAJUNK GmbH Medizintechnologie | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 1 |
| 2002 | 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.
1 device in this family has a Class I recall. 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 FCG device
- #1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 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? (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 |
|---|---|---|---|
| * | K013692 | Trapsystem SetSummary page 1…1612 Regulatory Class: II Product Code: KNW, FCG Panel: Gastroenterology/Urology Predicate Devices: 1. K013692 TrapSystem, manufactured by MDTech 1. K05I60B Sterylab Bone Biopsy PMN TrokaBone… | 2002 |
| * | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Summary page 2…of bone marrow from the sternum area. Predicate Devices: Predicate devices with the same indications of use are: 2. K013692 TrapSystem, manufactured by MDTech 3. K051506 Sterylab Bone Biopsy The detailed description of substantial eqivalence outlining relevant parameters can be found in Section 12… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All FCG devicesFCG Biopsy Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FCG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCG
82in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FCG
5in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCG
632in 2025
MAUDE reports naming product code FCG, 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 | 4 | 32 | 0 | 11 |
| 2008 | 1 | — | 19 | 115 |
| 2009 | 4 | 87 | 5 | 270 |
| 2010 | 3 | 18 | 4 | 73 |
| 2011 | 1 | — | 2 | 71 |
| 2012 | 0 | — | 0 | 107 |
| 2013 | 1 | — | 0 | 130 |
| 2014 | 5 | 88 | 0 | 154 |
| 2015 | 4 | 91 | 0 | 124 |
| 2016 | 3 | 63 | 0 | 191 |
| 2017 | 3 | 166 | 0 | 273 |
| 2018 | 6 | 140 | 0 | 282 |
| 2019 | 0 | — | 0 | 229 |
| 2020 | 1 | — | 0 | 240 |
| 2021 | 1 | — | 5 | 290 |
| 2022 | 2 | — | 0 | 302 |
| 2023 | 4 | 82 | 0 | 428 |
| 2024 | 1 | — | 0 | 446 |
| 2025 | 2 | — | 0 | 632 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Pajunk's TrokaBone puncture set consists of a modular system for the extraction of bone and bone marrow samples for histological examinations.
The TrokaBone Sternal device is intended for the aspiration of bone marrow from the sternum area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070179: Trokabone, Trokabone Sternal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070179
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