510(k) · Cleared
ClearedElite SPK, Compasso, Elite SPK Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ncs Lab Srl · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Apr 20, 2016 as substantially equivalent to K120356 (Ncs Lab Srl, 2012) after a 57-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Apr 20, 2016
- Review
- 57 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K911837 (1991). 86 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 7 generations between
- 3 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 2 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 1 generation backK120356 NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl · 2012
- This deviceK160500 Elite SPK, Compasso, Elite SPK KitNcs Lab Srl · 2016
Show all 11 generations
- Root · 11 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
- 10 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
- 9 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
- 8 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
- 7 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
- 6 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
- 5 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
- 4 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
- 3 generations backK091549 Conmed Linvatec Soft Tissue to Bone SystemLinvatec Corp. · 2009 · Recalled
- 2 generations backK111779 Y-Knot All-Suture Anchor Model HF13Conmed Linvatec · 2011
- 1 generation backK120356 NCS Fish-Fit MD System Fish-Fit MD Compass MDNcs Lab Srl · 2012
- This deviceK160500 Elite SPK, Compasso, Elite SPK KitNcs Lab Srl · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911837 | Suretac Polyglyconate Absorbable Fixation Device | Acufex Microsurgical, Inc. | 1991 | — |
| −10 | K973849 | Bioabsorbable Bankart Tack | Hogan & Hartson | 1998 | — |
| −9 | K992567 | Anatomical Bankart Tack, Model 523520A | Bionx Implants, Ltd. | 1999 | — |
| −8 | K003970 | Contour Labral Nail, Model 533520A | Bionx Implants, Inc. | 2001 | — |
| −7 | K020056 | Duet Suture Anchor | Bionx Implants, Ltd. | 2002 | — |
| −6 | K030388 | Impact Suture Anchor. Model 433510 | Bionx Implants, Ltd. | 2003 | — |
| −5 | K042966 | Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models… | Linvatec Biomaterials, Ltd. | 2004 | — |
| −4 | K053561 | Bio-Mini Revo Suture Anchor | Conmed Linvatec | 2006 | — |
| −3 | K091549 | Conmed Linvatec Soft Tissue to Bone System | Linvatec Corp. | 2009 | 1 |
| −2 | K111779 | Y-Knot All-Suture Anchor Model HF13 | Conmed Linvatec | 2011 | — |
| −1 | K120356 | NCS Fish-Fit MD System Fish-Fit MD Compass MD | Ncs Lab Srl | 2012 | — |
| 0 (this device) | K160500 | Elite SPK, Compasso, Elite SPK Kit | Ncs Lab Srl | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 12 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 MBI? 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 MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K120356 | NCS Fish-Fit MD System Fish-Fit MD Compass MDSummary page 5…Orthopedic 3 PREDICATE DEVICE The predicate device is as follows: • NCS Lab Srl’s NCS Sharc FT System, which was cleared through 510(k) application K120356.1 The following reference device was considered in analysis of the technological characteristics of the device materials and cer… | 2012 |
| † | K122314 | Quatro Link Knotless Anchor with Inserter, 2.9MM-Peek Only | 2012 |
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 25 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 9 of the 86 ancestors have a recall of any class.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, 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 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments.
Compasso is a series of surgical instruments intended for use for the implantation of the Elite SPK or the Sharc-FT bone anchor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160500: Elite SPK, Compasso, Elite SPK Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160500
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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