510(k) · Cleared
ClearedSynchro-Medical TIGER TRACK Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synchro Medical · HWC Screw, Fixation, Bone
Cleared on Aug 7, 2015 as substantially equivalent to K043142 (Inion, Ltd., 2005) and 14 other predicates after an 88-day review. Its family tree reaches back 13 generations to 1991. 1 of the 392 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 7, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 13 generations to K911686 (1991). 391 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 392 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
- This deviceK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- 1 generation backK120739 Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc. · 2012
- This deviceK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −6 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −5 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −4 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −2 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| −1 | K120739 | Aequalis Adjustable Modular Reverse Shoulder System | Tornier, Inc. | 2012 | — |
| 0 (this device) | K151241 | Synchro-Medical TIGER TRACK Screw System | Synchro Medical | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1980 | 3 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 29 | 0 |
| 1997 | 15 | 0 |
| 1998 | 17 | 0 |
| 1999 | 23 | 0 |
| 2000 | 22 | 0 |
| 2001 | 29 | 0 |
| 2002 | 19 | 0 |
| 2003 | 18 | 0 |
| 2004 | 14 | 0 |
| 2005 | 31 | 0 |
| 2006 | 28 | 0 |
| 2007 | 25 | 0 |
| 2008 | 10 | 0 |
| 2009 | 12 | 0 |
| 2010 | 10 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (15)
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 |
|---|---|---|---|
| * | K043142 | Inion Otps Biodegradable Mini Plating SystemSummary page 4…threaded metallic bone fixation fastener and Number 21 CFR 888.3040 Classification Panel: Orthopedic Product Code HWC Predicate Devices (K043142 & K030900) Inion Ltd., OTPSTM Biodegradable Screws; (K131722), I.T.S GmbH, Extremity Fixation Systems; (K… | 2005 |
| * | K030900 | Inion Otps Biodegradable Fixaton SystemSummary page 4…metallic bone fixation fastener and Number 21 CFR 888.3040 Classification Panel: Orthopedic Product Code HWC Predicate Devices (K043142 & K030900) Inion Ltd., OTPSTM Biodegradable Screws; (K131722), I.T.S GmbH, Extremity Fixation Systems; (K041189), A… | 2003 |
| * | K131722 | I.T.S. Extremity Fixation SystemsSummary page 4…ssification Panel: Orthopedic Product Code HWC Predicate Devices (K043142 & K030900) Inion Ltd., OTPSTM Biodegradable Screws; (K131722), I.T.S GmbH, Extremity Fixation Systems; (K041189), Arthrex, TRIMit Family; (K071540) Small Bone Innovat… | 2013 |
| * | K041189 | Arthrex Trimit FamilySummary page 4…HWC Predicate Devices (K043142 & K030900) Inion Ltd., OTPSTM Biodegradable Screws; (K131722), I.T.S GmbH, Extremity Fixation Systems; (K041189), Arthrex, TRIMit Family; (K071540) Small Bone Innovations International, SBI Tit… | 2004 |
| * | K071540 | Sbi Titanium Threaded PinSummary page 4…Ltd., OTPSTM Biodegradable Screws; (K131722), I.T.S GmbH, Extremity Fixation Systems; (K041189), Arthrex, TRIMit Family; (K071540) Small Bone Innovations International, SBI Titanium Threaded Pin, Percufix; (K041456) & (K070617), Fourni… | 2007 |
| * | K041456 | Snap-Off ScrewsSummary page 4…(K041189), Arthrex, TRIMit Family; (K071540) Small Bone Innovations International, SBI Titanium Threaded Pin, Percufix; (K041456) & (K070617), Fournitures Hospitalières Industries, Snap-off Screws & Cannulated Screws; (K895389),… | 2004 |
| * | K070617 | Cannulated ScrewSummary page 4…Arthrex, TRIMit Family; (K071540) Small Bone Innovations International, SBI Titanium Threaded Pin, Percufix; (K041456) & (K070617), Fournitures Hospitalières Industries, Snap-off Screws & Cannulated Screws; (K895389),… | 2007 |
| * | K895389 | Depuy (TM) True Compression ScrewSummary page 4…Titanium Threaded Pin, Percufix; (K041456) & (K070617), Fournitures Hospitalières Industries, Snap-off Screws & Cannulated Screws; (K895389), Biomet, (Ex-Depuy), S.O.C Pin; (K063298), OsteoMed L. P., Headless Cannulated S… | 1989 |
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 4…7), Fournitures Hospitalières Industries, Snap-off Screws & Cannulated Screws; (K895389), Biomet, (Ex-Depuy), S.O.C Pin; (K063298), OsteoMed L. P., Headless Cannulated Screw System; (K132912) In2Bones, DUAFIT Interphalangeal… | 2007 |
| * | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantSummary page 4…annulated Screws; (K895389), Biomet, (Ex-Depuy), S.O.C Pin; (K063298), OsteoMed L. P., Headless Cannulated Screw System; (K132912) In2Bones, DUAFIT Interphalangeal Implant; (K130859), Arthrosurface, Hammertoe Correction System,… | 2014 |
| * | K130859 | Hammertoe Correction SystemSummary page 4….C Pin; (K063298), OsteoMed L. P., Headless Cannulated Screw System; (K132912) In2Bones, DUAFIT Interphalangeal Implant; (K130859), Arthrosurface, Hammertoe Correction System, (K120739) Tornier, Aequalis Adjustable Modular Reverse Shou… | 2013 |
| * | K120739 | Aequalis Adjustable Modular Reverse Shoulder SystemSummary page 4…Screw System; (K132912) In2Bones, DUAFIT Interphalangeal Implant; (K130859), Arthrosurface, Hammertoe Correction System, (K120739) Tornier, Aequalis Adjustable Modular Reverse Shoulder System; (K133036) Amendia, Apollo Suture Anchor Sy… | 2012 |
| * | K133036 | Apollo Suture Anchor System and Titan ScrewsSummary page 4…59), Arthrosurface, Hammertoe Correction System, (K120739) Tornier, Aequalis Adjustable Modular Reverse Shoulder System; (K133036) Amendia, Apollo Suture Anchor System, (K133235) Threaded Peek K-Wire MTP Solutions, and (K022599) Newdea… | 2014 |
| * | K133235 | Threaded Peek K-WireSummary page 4…(K120739) Tornier, Aequalis Adjustable Modular Reverse Shoulder System; (K133036) Amendia, Apollo Suture Anchor System, (K133235) Threaded Peek K-Wire MTP Solutions, and (K022599) Newdeal K Wire.… | 2014 |
| * | K022599 | Newdeal K WireSummary page 4…verse Shoulder System; (K133036) Amendia, Apollo Suture Anchor System, (K133235) Threaded Peek K-Wire MTP Solutions, and (K022599) Newdeal K Wire. K151241 page 2 of 5 Previous Submissi… | 2002 |
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.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 66 of the 391 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K043142.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The TIGER TRACK® screw system is intended for small bone extremities and large/long bone reconstruction fixation/arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK® screw system is intended to be permanently implanted without any other additional device and are delivered sterile. The TIGER TRACK® screw system, for diameters 3.5mm or smaller(1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated for use in fixation for…
Read the full statement (234 words)
The TIGER TRACK® screw system is intended for small bone extremities and large/long bone reconstruction fixation/arthrodesis procedures for general use in skeletally mature individuals. The TIGER TRACK® screw system is intended to be permanently implanted without any other additional device and are delivered sterile.
The TIGER TRACK® screw system, for diameters 3.5mm or smaller(1.8mm, 2.2mm, 2.5mm, 2.9mm, 3.0mm), is indicated for use in fixation for small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; Weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments). ulnar styloid fractures, radial head fractures, capirellumn fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.
The TIGER TRACK® screw system, for diameters 4.5mm and 7.0mm, is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hind foot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen screw should be adapted to the specific indication.
The TIGER TRACK® screw system is not for spinal use. The devices described in this manual must be accompanied with a form of immobilisation suited to the pathology being treated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151241: Synchro-Medical TIGER TRACK Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151241
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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